Regulatory Affairs

Management of Clinical Supplies Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral …

ACTD, CTD, and eCTD Dossier Compilation & Service Provider: Simplifying Regulatory Submissions Introduction In the pharmaceutical industry, the submission of comprehensive and well-organized dossiers is essential for obtaining regulatory approvals and bringing new drugs to market. Dossier compilation and submission processes have evolved over time, with the adoption of standardized …

Unlocking the Significance of Bioequivalence Studies: Ensuring Therapeutic Equivalence in Pharmaceutical Products Bioequivalence studies play a pivotal role in the development, regulation, and availability of generic drugs. These studies are essential in demonstrating that generic drugs are therapeutically equivalent to their reference or innovator products, ensuring their safety, efficacy, and …

Unlocking the Significance of Import License or Form-10: A Comprehensive Guide to Importing Regulated Products Importing regulated products involves navigating complex regulatory landscapes and adhering to specific requirements to ensure compliance and quality. An integral component of the importation process is the Import License, commonly known as Form-10. This document …

Demystifying Import Test License or Form-12: Ensuring Compliance and Quality in Importing Regulated Products Importing regulated products requires adherence to specific regulations and procedures to ensure compliance with quality standards and regulatory requirements. One such requirement is the Import Test License, also known as Form-12. This document plays a crucial …

Import Registration of Biological Products: Ensuring Safety and Efficacy in Healthcare Biological products play a significant role in modern healthcare, offering innovative treatments and preventive measures for various diseases. The importation of biological products is subject to strict regulations and oversight to ensure their safety, efficacy, and quality. Import registration …

Navigating the Import Registration of Medical Devices: Ensuring Safety and Compliance The importation of medical devices plays a vital role in providing healthcare solutions worldwide. Import registration of medical devices is a critical process that ensures the safety, quality, and efficacy of these devices before they are distributed in a …

Navigating the Import Registration of Drugs and Active Pharmaceutical Ingredients (API): Ensuring Quality, Safety, and Compliance The importation of drugs and Active Pharmaceutical Ingredients (APIs) is a critical aspect of the pharmaceutical industry. Import registration plays a pivotal role in ensuring the quality, safety, and compliance of these essential healthcare …

Unveiling the Importance of Periodic Safety Update Reports (PSUR) in Pharmacovigilance In the realm of pharmacovigilance, where patient safety is of paramount importance, Periodic Safety Update Reports (PSURs) play a crucial role. PSURs are comprehensive documents that provide a systematic and structured analysis of the safety profile of a medicinal …

Navigating the Import Registration of Cosmetics: Ensuring Safety and Compliance The importation and distribution of cosmetics require careful regulation and oversight to safeguard consumer health and maintain product quality. Import registration of cosmetics plays a crucial role in ensuring that cosmetic products meet regulatory standards, adhere to safety requirements, and …