Regulatory
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Regulatory Affairs – Overview
Regulatory Affairs (RA) is a critical function in the pharmaceutical, biotechnology, and medical device industries. It ensures that products are developed, manufactured, tested, approved, marketed, and distributed in compliance with regulations and laws established by regulatory authorities.
Regulatory professionals act as a bridge between companies and regulatory agencies, ensuring that all activities meet the required legal and scientific standards.
Objectives of Regulatory Affairs
To ensure the safety, efficacy, and quality of pharmaceutical products.
To facilitate regulatory approvals for new drugs, biologics, and devices.
To ensure compliance throughout the product lifecycle.
To maintain ongoing communication with regulatory agencies.
To prepare and submit necessary regulatory documentation.
Types of Regulatory Submissions
IND (Investigational New Drug)
CTA (Clinical Trial Application)
NDA (New Drug Application)
ANDA (Abbreviated NDA – for generics)
BLA (Biologics License Application)
DMF (Drug Master File)
MAA (Marketing Authorization Application – EU)
