Regulatory

At Vedic Lifesciences the Regulatory team provides expert guidance on regulatory strategy for FDA, FTC, EFSA, NHPD, FSANZ, NPCB and successful management of Regulatory review processes of Nutraceutical, Cosmeceuticals and Indian Traditional Healthcare Products+C30.

Key areas of support:

• Regulatory Strategy input to the Product Development Plan
• Preparation and compilation of regulatory submissions and protocols
• Development, writing, publishing and submission of: IND, CTA, NDA, ANDA
• Application for an Ethics Committee opinion
• Type B meetings with successful defense of strategy
• Clinical trial application to National Health authorities for conduct of clinical trial

Vedic Lifesciences provides a range of regulatory services in different phases of a product life cycle. This could vary from molecule development to commercialization and post marketing. At Vedic we offer our clients an opportunity to understand the regulations surrounding the marketing of products to both the emerging & regulated markets