Vinit Movaliya
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View article: Regulatory and Quality Compliance of Oncology Products – A Global perspective
Regulatory and Quality Compliance of Oncology Products – A Global perspective Open
The development and manufacturing of oncology products pose unique challenges in ensuring both regulatory compliance and high-quality standards. Oncology products, often complex biopharmaceuticals, play a critical role in cancer treatment,…
View article: Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines
Comparative Study of Analytical Method Validation and Process Validation parameters as per ICH, EMA, WHO and ASEAN guidelines Open
Objective: Compare and analyse analytical method validation and process validation requirements across ICH, EMA, WHO, and ASEAN guidelines, alongside relevant literature. Summary: In the pharmaceutical industry, ensuring the quality, safet…
View article: Regulatory requirements for approval and Registration Procedure of Biosimilar in US and European Union (EU)
Regulatory requirements for approval and Registration Procedure of Biosimilar in US and European Union (EU) Open
The market for biotechnology-derived medicinal products is evolving rapidly with the imminent entry of biosimilars. The development and approval of biosimilars represent a critical pathway to expanding access to biological therapies while …
View article: Overview of Post-approval Submissions Management in US, Europe and Canada
Overview of Post-approval Submissions Management in US, Europe and Canada Open
In today’s business era & competition in pharmaceutical industries, post-approval evaluation & cGMP compliance plays an important role. Regulatory approval is a critical milestone in the lifecycle of pharmaceuticals and medical devices, en…
View article: Similarities and differences in filing for Drug Master File in US, Canada and Europe
Similarities and differences in filing for Drug Master File in US, Canada and Europe Open
Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the applicable authority in the intended drug market. The document provides the non-supervisory authority with confid…
View article: A comparative evaluation of Regulatory requirements for Registration of Dietary Supplements in Brazil, Russia, India, China and South Africa
A comparative evaluation of Regulatory requirements for Registration of Dietary Supplements in Brazil, Russia, India, China and South Africa Open
Nutraceuticals are products that are rich in nutrients and provide health benefits, because of many factors like lifestyle changes and change in the dietary habits of people now a day, these products are widely used. Among all the other ca…
View article: Regulatory Prospective on Software as a Medical Device
Regulatory Prospective on Software as a Medical Device Open
Software is becoming increasingly important in medical devices and digital adoption more broadly. It is becoming more important as a medical device in its own right. (1) Currently the use of software in medical market is growing exponentia…
View article: Comparisons of registration requirements of Nutraceuticals in Philippines, Tanzania, Cambodia and India
Comparisons of registration requirements of Nutraceuticals in Philippines, Tanzania, Cambodia and India Open
"Nutraceuticals" are the combination of Nutrition and pharmaceutical. The term Nutraceutical was given by Dr. Stephen in 1989. A dietary supplement is a product taken by mouth that contains a dietary ingredient (Vitamins, Minerals, Herbs, …
View article: FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications Open
This review paper is about FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications (KASA). The aim of USFDA is Timely development, assessment, and approval of safe and effective drugs is pivotal fo…
View article: Comparison of Dietary Supplements Product Registration requirements in Singapore, Malaysia, Ghana, Zimbabwe and India
Comparison of Dietary Supplements Product Registration requirements in Singapore, Malaysia, Ghana, Zimbabwe and India Open
Nowadays, diet is thought to be much richer than it used to be. The people’s ignorance of the basic principles of nutrition has led a large part of the population to a non-balanced diet that is high in both calories and fat and low in prot…
View article: Regulatory requirement for the approval of Generic Drug in Vietnam as per ASEAN Common Technical Dossier (ACTD)
Regulatory requirement for the approval of Generic Drug in Vietnam as per ASEAN Common Technical Dossier (ACTD) Open
Drug approval process differs from one country to another country. The purpose of this study is to give a comparative overview on generic drug market regulation in ASEAN Countries Cambodia and Vietnam. The aim of study is to facilitate pro…
View article: Assessment of suitability of saxagliptin hydrochloride for development of controlled release parenteral formulation by preformulation studies
Assessment of suitability of saxagliptin hydrochloride for development of controlled release parenteral formulation by preformulation studies Open
The main objective of pre-formulation study is to develop the stable, elegant, safe and effective drug delivery system by establishing drug kinetic profile, formulation compatibility with different excipients and physico-chemical parameter…
View article: Preformulation Study of Glimepiride: An Insight for Formulation and Development of Parenteral Formulation
Preformulation Study of Glimepiride: An Insight for Formulation and Development of Parenteral Formulation Open
Aim: The objective of preformulation study is to develop the elegant, stable, effective and safe dosage form by establishing kinetic profile, compatibility with other formulation excipients and physico-chemical parameters of new drug subst…
View article: In Vitro Nephroprotective Activity of Selected Herbal Plants on Vero Cell Line
In Vitro Nephroprotective Activity of Selected Herbal Plants on Vero Cell Line Open
Nephrotoxicity is common side effect of many drugs like anticancer, aminoglycoside antibiotic and radioactive compounds. In allopathy there is no effective treatment for the cure of kidney diseases. Aerva javanica, Ocimum basilicum and Kal…
View article: Development and standardization of novel herbal formula for the management of kidney disease
Development and standardization of novel herbal formula for the management of kidney disease Open
Herbal medicine is the oldest form of health care known to mankind. It is an integral part of the development of modern civilization. Ancient literature has prescribed various herbs for the cure of kidney disease. The term Pasanabheda has …
View article: Assessment of diurnal variation in Ocimum sanctum Linn. by gas chromatographic fingerprint analysis coupled with chemometric methods
Assessment of diurnal variation in Ocimum sanctum Linn. by gas chromatographic fingerprint analysis coupled with chemometric methods Open
Vast intra-specific variations, especially diurnal, geographical and seasonal, have been reported in the chemical composition of essential oils of Ocimum species. The study was conducted to assess diurnal variation in the chemical composit…