Category Archives: Updates

Enhancing Consensus Research in Biomedicine: The Advent of ACCORD Guidelines

Updates

The introduction of the ACCORD (ACcurate COnsensus Reporting Document) guidelines marks a pivotal advancement in consensus-based research within biomedicine. These guidelines aim to improve how consensus methods are documented ensuring that studies are transparent, comprehensive, correctly interpreted, and applied by the medical and research communities.

The Need for ACCORD

Reporting of consensus has been fraught with several challenges, including inadequate and incomplete documentation. This has often led to difficulties in understanding, interpreting, and applying research findings effectively. The ACCORD guidelines emerge as a beacon of hope, offering a comprehensive framework designed to address these issues head-on.

What is ACCORD?

ACCORD is a pioneering guideline focused on consensus methods used in biomedical research reporting. Developed through a rigorous process involving a systematic review and a modified Delphi method, ACCORD aims to standardize the reporting of consensus studies. Thereby, enhancing the quality of research outputs, and facilitating better decision-making in clinical recommendations, policy formation, and priority setting.

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The Development Process

The development of ACCORD involved a systematic review of existing literature and inputs from a diverse panel of experts across six continents. The collaborative effort culminated in a checklist of 35 items that covered various reporting aspects, including the study’s introduction, methods, results, and discussion. This structured approach ensures the transparent and comprehensive conveyance of all crucial information.

Benefits of ACCORD

The ACCORD guidelines offer numerous benefits to the biomedical research community:

Improved Transparency: By adhering to a standardized reporting format, researchers can more transparently present their methods and findings.

Enhanced Trust: Comprehensive and clear reporting builds trust among the scientific community, policymakers, and the public.

Facilitated Application: Detailed documentation allows for the critical interpretation and application of research findings.

Cross-Methodology Applicability: ACCORD is the first guideline applicable across all consensus methodologies, making it a versatile tool for researchers.

Looking Ahead

As we move forward, the adoption of ACCORD by journal editors, publishers, and researchers will be crucial. It aligns with other established reporting guidelines, such as CONSORT and PRISMA, emphasizing the collective effort towards enhancing research quality. Turacoz Healthcare Solutions supports and encourages the biomedical research community to embrace ACCORD, contributing to a more transparent, reliable, and effective consensus-building process.

Get in Touch

For more information on how our consensus-building services can support your research or policy-making needs, please contact us at [email protected] . Our team is ready to assist you in leveraging consensus methods to their fullest potential, guided by the latest advancements in reporting standards.

Here is Everything You Should Know About Cystic Fibrosis

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The month of May is commemorated as Cystic Fibrosis Awareness Month. It aims at raising awareness about cystic fibrosis (CF). Cystic fibrosis foundation (CFF) sponsors this month.

According to estimates, more than 70,000 people globally are affected by cystic fibrosis, but the prevalence of the condition varies globally. The US alone accounts for around 30,000 people living with cystic fibrosis. Around 1000 new cases of cystic fibrosis are diagnosed every year in the US. More than 75% of these cases are of children of age 2 or below. Asia and Africa are thought to be under-diagnosed for CF. Many nations don’t screen for CF in new-borns unlike the US, and the nation registries suffer from lack of data.

What is Cystic Fibrosis (CF)?

CF is a genetic disease that has an impact on lungs and digestive system of human body. Under the influence of this condition, the body produces thick and sticky mucus that can lead to blockage of lungs and obscure pancreas.

In individuals with CF, metamorphosis in the cystic fibrosis transmembrane conductance regulator (CFTR) gene makes the CFTR protein debilitated. When this protein doesn’t function properly, it is incapable of moving chloride- a salt component- to the surface of cell. Without the chloride to bring water to the surface of cell, the mucus in different organs turns thick and sticky.

The mucus blocks the airways and entrap germs such as bacteria, in the lungs, which lead to infections, soreness, respiratory issues and other complications. The people with CF need to be extra cautious and avoid contact with germs.

The thickening of mucus can also lead to infertility in males by clogging the vas deferens or the tube responsible for carrying sperms from testes to urethra.

Symptoms of CF:

Mentioned below are some prominent symptoms of cystic fibrosis:

  • Skin tasting very salty
  • Continual coughing
  • Running out of breath
  • Breathing roughly/heavily
  • Persistent lung infections inclusive of pneumonia or bronchitis
  • Problem with gaining weight despite of heavy diet
  • Infertility in males
  • Greasy and heavy stools
  • Troubles with bowel movements
  • Nasal polyps or slight fleshy growth in the nose

Due to the obstruction in lungs, infections like bronchitis and pneumonia can occur in the patient, leading to growth of pathogens. Blockage in pancreas contribute to malnutrition and poor growth. The risk of developing osteoporosis and diabetes is also associated with it.

Causes of Cystic Fibrosis:

Since CF is a genetic disease, to be affected by it one is required to inherit the mutated gene from both of their parents. The mutated genes are the carriers of codes that produce protein controlling the flow of salt and water on the surface of organs, inclusive of pancreas and lungs.

People suffering from CF struggle with the balance of salt and this leads to more salt and water on the surface of cells and formation of very thick mucus.

Individuals with a single copy of the mutated gene are known as carriers. They do not fall prey to the condition or symptoms of CF. For someone to be affected by CF, both their parents must be the carriers.

If two people are carriers and have a child together, there are:

  • 25% chances that the kid will have CF
  • 50% chances that the kid will be a carrier, but won’t suffer from CF
  • 25% chances that the kid will neither be the carrier and nor suffer from CF

Treatment for CF:

At present, CF is not curable. Certain treatments work on controlling the symptoms and improving quality of life for CF patients. Depending on the kind and intensity of symptoms, the treatments are personalized.

Clearing airway

It is very important for CF patients to reduce the level of mucus in their lungs in order to breathe easily and avoid any lung infections.

Airway Clearance Techniques (ACT) helps individuals with CF to soften their mucus and get rid of it from their lungs. Inhalable medications are effective in reaching the airways and are usually used. The medication can be given through aerosol or through inhalers. These medications help in thinning mucus, killing bacteria and setting off mucus to enhance airway clearance.

Antibiotics act as an essential part of routine care. These can be consumed orally, through injecting and inhalation. Some other medications like azithromycin and ibuprofen are said to protect and enhance lung function and now made a part of standard therapy for CF patients.

CF patients can lower the risk of developing lung infections by taking the below mentioned steps:

  • Washing hands often
  • Avoid smoking
  • Avoid futile contact with people suffering from cold or other contagious diseases
  • Getting a flu injection every year

Other styles of treatment:

Other than the airway clearance technique, there are other types of treatment too.

Implanted devices:

These allow long-term contact with the bloodstream for constant supervision of drugs. These are capable of making the management of CF more powerful and less invasive.

CFTR Modulators:

CFTR (CF Transmembrane Conductance Regulator) modulators are the recent medications developed to focus on the defective CF-causing gene. They help in easing the flow of salt and fluids on the expanse of lungs and weed out the heavy mucus that CF patients generally form in their lungs.

At present, two CFTR modulator brands are certified by FDA (Food and Drug Administration), namely Orkambi and Kalydeco. They’re recommended for children suffering from 10 distinct mutations of the CF-causing gene. Kalydeco might be recommended for kids of age 2 years or more, whereas Orkambi is for kids aged 6.

Remedial measures based on Nutrition:

CF affects the digestive system adversely and the patient suffers from poor nutrient absorption. It is recommended that CF patients should consult their doctor regarding their diet. A nutritionist would assist them in having a control of digestive symptoms.

To balance the digestion of nutrients, a variety of additional supplements like pancreatic enzyme supplements, vitamins or salt might be required along with a specific kind of diet.

CF is responsible flawed growth. To ensure proper development and growth in affected children, a diet rich in calorie and fat, is very essential. It also helps adults in maintaining optimum health. Good nutrition is very crucial for CF patients so that they can be safeguarded against high risk of lung infection.

Cystic fibrosis cannot be cured as of now but with proper care, treatment and diet, the symptoms of it can be controlled. The average life expectancy of CF patients is early 40s. The life expectancy may vary based on the intensity of the symptoms, age of diagnosis and the kind of mutation in gene.

The life expectancy of CF patients has increased significantly in last few years, being around 47 years. There are many patients living well in their 50s or 60s.

Turacoz healthcare solutions, a medical communications firm, believes that appropriate treatment and caution is the key to control currently incurable diseases like cystic fibrosis. Turacoz provides cost-effective medical writing services like regulatory writing, publication writing, advisory board meetings, etc. To know more about Turacoz and to avail the services, drop a mail at [email protected]

Talc, a cosmetic ingredient: Safety issues

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Most of us have possibly used it or sprinkled on our skin at some point in our life, ‘Talc’ which is a processed from of soft mineral compound of magnesium silicate and is called talcum powder or just talc in general terms. The natural smoothness and adsorbency of talc have been utilized since millennia and its use dates back to the Egyptian time. Some of the major brands utilizing talc’s adsorbent properties are Nivea, Pond’s, Cinthol and Johnson & Johnson. Ideally, cosmetic grade talc should not contain asbestos but recent lawsuits against Johnson & Johnson have claimed its presence in the marketed cosmetic products.

Non-clinical Findings

In 1993, the National Toxicology Program (NTP) in their report stated that there were some evidence of carcinogenic activity in male F344/rats, clear evidence of carcinogenic activity in female F344/N rats, and no evidence of carcinogenic activity in male or female B6C3F1 mice exposed to aerosols of 6 or 18 mg/m3 non-asbestiform cosmetic grade talc in a lifetime study. In 2010, the International Agency for Research on Cancer (IARC) Working Group reported that there is a limited carcinogenicity evidence for talc (not containing asbestos/asbestiform fibres) in experimental animals.

Clinical Safety Alerts

Talc has been safely used and is well tolerated since many years and recent scientific reviews on available data have supported this position lately. However, the first alert associated with genital was reported by identification of talc particles in ovarian cancers which came in 1971.

This finding was strongly contested by Dr G.Y. Hildick-Smith, Johnson & Johnson’s medical director. A subsequent publication in the Lancet warned that “The potentially harmful effects of talc in the ovary should not be ignored”. This warning was confirmed in a 1992 Obstetrics & Gynaecology publication, reporting that a woman’s frequent talc uses on her genitals increased her risk of ovarian cancer by threefold. The talc in question was simple brand or generic ‘baby powder’.

Unexpectedly, the mortality of ovarian cancer in women over 65 years of age has escalated sharply, especially in black women who have a higher rate of talc use as compared to other races. Almost 16,000 women in the United States die from ovarian cancer yearly, by some estimates, one out of five women regularly applies talc to her genitals either via direct application, or from tampons, sanitary pads and diaphragms that have been dusted with talc.

Conclusion

IARC reports perineal use of talc-based body powder to be possibly carcinogenic (Group 2B) in humans, and that inhaled talc (without asbestos or asbestiform fibres) is not classifiable as to its carcinogenicity (Group 3). Additionally, the US Cosmetic Ingredient Review Expert Panel published a safety assessment of talc as used in cosmetics. It concluded that talc is safe for use in cosmetics in the present practices of use. Johnson & Johnson faced continued concerns on about the threat posed by lawsuits over the safety of the company’s signature baby powder. The company has always denied the allegations and maintained a swift stance on the safety of talc.

At Turacoz Healthcare services, we provide end to end toxicology and regulatory assistance to meet the high standards set by the regulators worldwide. We provide exhaustive toxicology/safety literature search from pre-clinical to post-marketing stage. We provide consultation at various stages of product lifecycle in order support the ingredient compliance with the guidelines of respective regulatory bodies.

Medical Diagnostics: An Update

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Diagnostics play a very important role in our everyday life, be it for a disease, condition or identification of a risk factor. Various diagnostic advancements viz. novel techniques, devices, pathology and laboratory services, etc. are introduced regularly in the market by companies across the globe to help improve the lives of people and ensure quality‑care for patients.

The first quarter of 2019 featured some important updates on medical diagnostic and innovations and some are shared below:

  • Paper-based LAMP Diagnostics for Detecting Malaria

According to the World Malaria Report 2018, 219 million people were affected by malaria in 2017. Diagnosing the same is difficult in rural areas and in developing countries. Keeping the disease burden and non-accessibility in mind, scientists have developed a low-cost portable device which accurately and efficiently detects malaria. The technique uses a paper infused with loop-mediated isothermal amplification, LAMP, which involves printing with hydrophobic wax using a commercial printer and then heating the paper on a hot plate to bind the wax with the paper [2]. The paper attached to a lateral flow device helps in containing the blood sample (DNA) for the detection of malaria. This device uses amplification and detection techniques which help in identifying Plasmodium falciparum, the malarial parasite. This device was used to detect malaria in 67 school children from 2 different schools in Uganda. The results were also compared to the gold standard test in malaria, PCR. The new device showed promising results by identifying 98% of the malaria cases and is now undergoing further research for proper implementation.

  • Objective Diagnosis for PTSD

Posttraumatic stress disorder is associated with functional impairment involving delayed-speech and substance abuse. Diagnosis of PTSD involves long-term counseling sessions which often tend to get biased owing to the subjective nature of the entire process. Also, patients are often reluctant and unwilling to visit the clinician in-order to avoid confrontation. Diagnostic biological markers, though available for PTSD related factors, are not cost-effective. Further, PTSD has a high disease burden which limits the success of these markers.

A software known as the random forest was developed by researchers which assesses speech patterns for variations in speech, lifeless, metallic tone of the speech along with animated speech using AI. It provided 89% accurate results in the tested participants. The software was fed with data on various speech patterns which it uses as training data to grasp better and provide suitable results. With the use of this preliminary information, clinicians can use naturally collected data for diagnosis of PTSD. This technique, however, is still under research and hopes to aid in the diagnosis of PTSD.

  • Blood Test for Detecting Breast Cancer Relapse

The second most common type of cancer-causing death in women is breast cancer. It can be detected using various methods such as mammography, ultrasound, etc. Although the survival rate has improved in comparison to earlier times, relapse is still a very important concern. Approximately 30% of the patients suffer through a relapse within 5 years. Natera, a genetic testing company has developed a blood test by the name of Signatera, which detects the mutant DNA released by the cancerous cells. The technique, known as Molecular Residual Disease (MRD) Assessment is used for early detection of breast cancer, enabling patients to take proper precautionary measures. This technique was found successful in 89% of relapse cases. The detection, however, has to be clinically confirmed for a confirmed diagnosis. The researchers aim to test this in a large number of the sample population in order to bring this into mainstream diagnostics.

  • New Diagnostic Manufacturing Facility Launches in India

Co-Diagnostics Inc. and Synbiotics Pvt Ltd, together in partnership have launched a diagnostic manufacturing facility in India. It is said to be a one-of-a-kind facility providing state of the art facilities in the world of diagnostics. The owners are known for developing facilities which have global approvals from the leading regulatory bodies (US Food and Drug Administration, World Health Organisation-Good Manufacturing Practices). This facility is not only ready to start operations in India but has plans underway for further expansion. Asence Inc, a US company which specializes in providing pharmaceutical products to various markets, would be managing the commercial operations for the facility.

  • VITROS® XT Chemistry Product Slides (FDA approved)

One factor that delays the diagnosis of various diseases is the delay in lab test results. These diagnostic tests are either time taking or are too many done at one time, which in turn delays the results. Ortho Clinical Diagnostics have come up with a new VITROS® XT MicroSlide which can run two tests simultaneously, thus reducing the time required to conduct these tests along with less usage of the products. Ortho’s VITROS XT MicroSlides, which are available for use on Ortho’s VITROS® XT 7600 Integrated System, provide high-quality results and are used for paired tests such as, triglycerides and cholesterol; urea and creatinine; and glucose and calcium. The miniature testing area in the slide is highly efficient and requires less amount of sample for providing results. With this FDA approved technique (approval received in October 2018), multiple tests can be done together, thus saving time and infrastructure.

Turacoz Healthcare Solutions aims to provide information on the latest trends, updates and advances in the field of clinical research, trials and regulatory affairs. Turacoz Healthcare provides an end-to-end support for scientific communications, clinical trial documents and disclosures, regulatory documents writing and submissions, and medico-marketing writing along with e-modules & e-books on healthcare and research.

Regulatory Troubles Clamping Down on OTC and Other Healthcare Products

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The regulatory authorities have been on fire lately. They are vigilantly sniffing any suspicious and harmful substance in healthcare and OTC (Over the Counter) products. They are working towards the standardization of products which has added to the woes of some famous names as well.

Everything going wrong with Johnson & Johnson (J&J)

The most popular baby product brand Johnson & Johnson lands into trouble again. This time The Rajasthan Drugs Control Organization has indicated that two batches of company’s “No More Tears Baby Shampoo” had ‘pernicious elements’, to which J&J, not long ago, has classified as carcinogen formaldehyde and has denied the test results.

Earlier, the baby powder of the company was also in news and that was because of no good reasons. The baby powder of the company was suspected of having asbestos (a cancer-causing element).

Only a month ago, the US healthcare colossal got clean chit from the government and proceeded again with the production of their baby powder at their plants in India. Now they are encountering troubles with the baby shampoo and are on the radar of domestic drug regulatory authorities.

This is a serious threat to the image of J&J and their well-established market in a place like India. Two batches of J&J’s baby shampoo failed the quality test, as per the reports by Indian Express. The samples of the batches BB58204 and BB58177, to be expired in September 2021, were tested positive for harmful and objectionable ingredients.

These samples containing one lakh bottles of “No More Tears Shampoo” were manufactured at Baddi, Himachal Pradesh. Rajasthan government has asked to withdraw these adulterated batches and has demanded the regulatory authorities of other states to follow the litigation.

The regulators found the presence of formaldehyde in the samples of shampoo. Formaldehyde has been declared as a probable carcinogen substance by the US Environmental Protection Agency. The studies conducted in past have shown a link between formaldehyde and a greater risk of leukemia.

Rajasthan drugs auditors relayed a notice to drug control officers to withdraw the available stock, so that the stocks of these drugs are not used by anyone and the consumers are safeguarded. Further, it was also notified to take appropriate actions in accordance with provisions of the Drugs and Cosmetics (D&C) Act 1940 and rules made afterwards.

J&J has though, denied any such allegations. It has claimed that neither did the government revealed the method of testing used and nor did it state the details and quantitative findings. A J&J spokesperson said that the samples were drawn at the start of this year and the company has extended full support during the whole process.

J&J stated that they had been inveterate to the Indian authorities that they have forbidden adding formaldehyde to their shampoos and nor does they use any such element in their shampoos that can release formaldehyde with time. J&J also claimed that their products are safe to consume and are manufactured in accordance with the standards of D&C Act and rules.

J&J has declared that they extend their full support to Indian regulatory authorities and act according to their regulatory requirements. The US healthcare giant has also applied for re-testing of their samples at Central Drugs Laboratory.

Adding to J&J’s anguish, Central Drugs Standard Control Organization (CDSCO) has planned to investigate the matter more scrupulously.

Reviewing of dispensations to Dettol, Savlon and other antiseptics, by the panel

Dettol, Savlon and other products of similar nature are liberated from getting a sale permit, as per Drugs and Cosmetics Rules, 1945. An expert panel now has been set up by Drug Controller General of India (DCGI), which will be deciding whether OTC healthcare products will be proceeding further with an exemption under disinfectants and antiseptics.

According to clause 12, schedule K of the Drugs and Cosmetics Rules 1945, “substances intended to be used for annihilation of vermin or insects, which produce disease in human beings or animals, like insecticides and disinfectants, can be stocked, exhibited and sold without a license.”

Currently products like Savlon, Dettol, etc. fall under the clause 12, schedule K. This ensures that they do not need any sales license. This matter, however, has now been consigned to a sub-committee for further investigation. It shall also be reviewed whether these products can be kept under the category of OTC products or ‘no-prescription’ products.

Dettol is a popular first-aid product, used as a disinfectant and it contains additives like terpineol, chloroxylenol and absolute alcohol. The reason for this action is to ensure the safety measure of these products. Such products, being a crucial part of infection control strategies in healthcare regimen, are required to be monitored closely. It is also because these products play a major role in antimicrobial resistance, so their manufacturing and usage becomes even more crucial.

The US Food and Drug Administration (FDA) also took a similar action in the year 2017, when it shut down the use of 24 elements in OTC antiseptic products like handwashes and surgical hand scrubs.

Things not going smooth for Claire

No one can deny the fact that cosmetics have been deeply rooted into the daily routine of our lives and hardly any woman walks out without wearing makeup or using any sort of cosmetic products. The widespread use of cosmetic products has made it even more important to screen them carefully in order to avoid any possible harmful effects.

With a wide range of cosmetic brands available, more vigilance is required. Recently, a popular cosmetic brand, named Claire, has been under the radar of FDA.

FDA called on Congress to alter the rules for cosmetic safety as it broadcasted an alert for consumers against 3 of the products sold by Claire Stores Inc. This was because these products were tested positive for asbestos- a product that causes cancer. The presence of any carcinogen element in any product is not acceptable.

The 3 products against which the warning was issued are:

  • Claire’s eye shadow palette
  • Contour Palette
  • Compact Powder

The retailer, who just escaped from the jaws of bankruptcy, stated that there is no proof that any of the product sold by Claire is risky. Though, as a measure of precaution, the retailer removed the stated 3 products from the store and any other such product that was talc-based.

Claire, however, has challenged the test results shown by FDA and says that it has misunderstood fibers present in the products as asbestos.

FDA has been under huge pressure to screen for any asbestos presence in the products, especially after the J&J case, where asbestos was found in their baby talcum powder. The reports from the Reuters stated that J&J was aware that their talc, in raw form, contains asbestos, from 1970s to early 2000s.

No favor to flavor: FDA plans on imposing restrictions on Flavored E-cigarettes sales to teens

The commissioner of FDA has decided to put a restriction on the sale of flavored e-cigarettes in order to minimize the rate of teenage vaping.

Vaping is practice of inhaling and exhaling vapors formed by an e-cigarette or electronic cigarette or any related device. The issue associated with this is that youngsters, especially teens might take up vaping as an alternative less harmful than smoking.

The agency has suggested in a proposal that the stores cloister flavored electronic cigarettes to areas prohibited to anyone falling below the age of 18. All retailers inclusive of departmental stores and gas stations will have to mandate the age verification of the customers.

There are enough proofs to show that youngsters are drawn towards flavored e-cigarettes and the minors have access to these from physical and online stores, despite of the fact that there are federal restrictions imposed on sale of such items to anyone below 18.

The increasing rates of teenage vaping is a serious concern over the past few years. Around 3.6 million middle and high school kids confirmed that they were involved in vaping, as per a study conducted by Centers for Disease Control and Prevention.

Previously, FDA repressed teenage vaping by issuing a threat warning to put a ban on maximum flavored e-cigarettes and asked retailers to stop selling them to minors.

The recent proposal states that the sellers need to filter the sale of such items according to the area. If any store caters to customers of all age group, then they might be required to have a separate space/room for such products, so that minors don’t have direct access to it.

Though many retailers aren’t happy with this and have even threated to fight against these stipulations in court. Conservative groups and vaping trade associations also seem to be in no mood for support and have stated that the efforts made by the agency to regulate e-cigarette industry corresponds to government overdo.

The new stipulations are not applicable on menthol, tobacco or mint flavors as the FDA wishes to keep them available for adults who are trying to quit volatile smoking with the help of e-cigarettes.

Meanwhile FDA plans to monitor the use of mint or menthol flavored e-cigarettes by the youth and upon finding excessive use by the youngsters, it would reconsider the exoneration of these products. This step is not going to be in favor of Juul labs, the vaping colossal. Juul has already shifted the sales of its products online, other than the mint and menthol flavored ones.

The proposal made is still in the draft phase and is required to abide by a 30-day comment period prior to its finalization. This regulatory approach is bit off-beat as it is neither an autonomous guideline nor a new rule. FDA has mentioned that if the e-cigarette manufacturers sell their products in contravention of the solicitation, then their products can be lifted off the market and asked to apply for approval from the agency. FDA can carry out this action under its discretionary enforcement authority.

With time, more emphasis is being given to the safety and efficacy of healthcare and cosmetic products. Proper measures should be taken to avoid the presence of any harmful substances in these products and ensure the safe usage. The safety and health of consumers is becoming a primary concern.

The regulatory authorities across the globe are working hard towards maintaining the standard of the manufacturing of these products by implementing stricter measures of screening and making amendments to the safety rules.

With the changing regulatory requirements and parameters, even the big giants need to buckle up and prepare for the best and ensure quality products from their end to stay out of any likely troubles. How things unfold in the future, would be a sight to see.

Turacoz Healthcare Solutions, being a medical communication firm, realizes the significance of drug safety and efficacy and believes that the manufacturing standards of the drugs and cosmetic products should be at par with the regulatory standards and rules. Consumer safety is a priority and the regulatory authorities are working on the same by fastening the grip on major healthcare and OTC product players, to ensure that the products are of standard quality and their consumption is safe.

Turacoz offers quality and cost-effective medical writing services. To know more about our services, write to us at [email protected]