Drug product development and CMC consulting
Make the next CMC decision with confidence. I help biopharma teams assess technical risks, plan development and manufacturing work, and communicate the evidence needed to move a program forward.
My consulting focus spans drug product development, CMC strategy and due diligence, regulatory CMC authoring and review, technology transfer, CDMO oversight, scale-up, validation readiness, and CMC program management.
Start a conversation
What CMC decision is in front of your team? Share the development stage, upcoming milestone, and the challenge you are trying to resolve.
Consulting Services
Scale-Up and PPQ
Connect process knowledge, sampling strategy, batch-size decisions, and manufacturing capacity planning to validation readiness.
Technology Transfer and CDMO Oversight
Plan transfers, evaluate external partners, coordinate manufacturing work, and address technical issues that affect timelines or product quality.
Regulatory CMC Authoring
Author or review CMC documentation for IND, NDA, and ANDA submissions, respond to regulatory questions, and translate technical findings for scientific, operational, and executive audiences.
CMC Program Management
Align cross-functional milestones, budgets, resources, risks, and CDMO deliverables with the development plan.
About Bharat
My background combines formulation and process development, manufacturing, regulatory CMC documentation, and cross-functional leadership. I have worked with internal teams and external CDMOs on drug-product development for small molecules.
My previous roles include Superluminal Medicines, Sanofi, Spero Therapeutics, and Lupin Pharmaceuticals. I hold a PhD in Industrial Pharmacy from St. John’s University and an MBA from the University of Illinois Urbana-Champaign.
Selected experience
- Technology transfer: Designed a scientifically justified proxy dissolution test after a discrepancy emerged and the development blend was exhausted, preserved limited API for scale-up, and kept the program on schedule.
- Commercial scale-up: Scaled a key process step from 400 kg to 1,100 kg, increasing commercial manufacturing throughput by 175%.
- CMC program leadership: Managed mRNA platform development teams and designed CMC budgets in excess of $15 million.
Writing and Perspective
I also write about the intersection of manufacturing, strategy, and innovation at BK talks Biopharm. Recent pieces include Manufacturing is now a Biopharma Strategy and Insidious CMC Risks in Regulatory Filings.
