Shraddha P.

I am a Regulatory Affairs & Clinical Development Consultant with 9+ years of experience helping pharma, biotech, and medtech companies navigate global regulatory pathways, accelerate early phase development, and optimize product portfolios. I have successfully: - Secured 40+ global drug approvals (FDA, EMA, ANVISA, COFEPRIS, DCGI, Thai FDA). - Led regulatory strategy, lifecycle management, and clinical operations for small molecules, biologics, and drug-device combinations. - Partnered with top pharma (e.g., Johnson & Johnson, Regeneron, Sanofi) and innovative startups to align development with regulatory and market expectations. - Designed and managed Phase I / BABE / 505(b)(2) studies, including CRO oversight, trial documentation, and submissions. - Provided portfolio analysis & product positioning, identifying therapy gaps and driving new product ideation. - Managed the successful completion of a client's ISO 9001:2015 Stage 1 audit 🔹 My Expertise Includes: - Global regulatory submissions (IND, NDA, MAA, ANDA, variations, controlled substances) - Clinical trial operations (protocols, reports, CRO management, HA interactions) - Early-phase drug development (proof-of-concept, 505(b)(2), biowaivers) -Portfolio strategy & lifecycle management -Regulatory intelligence & compliance monitoring I bring the strategic mindset of big pharma and the agility needed for startups, ensuring your projects stay compliant, efficient, and investor-ready.