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Sandeep Nema is an experienced CMC professional who has worked at start-ups (SalioGen, Tessera Therapeutics), mid size company (Mallinckrodt) and large pharma (Pfizer / Pharmacia). He has led teams and guided them from discovery up to Phase 3 and registration. At Pfizer, Sandeep was responsible for establishing Protein Pharmaceutical R&D group that included Microbiology and Stability functions. During his tenure at Pfizer he was a part of Pfizer Comparability Expert Working Group, Impurity Council and clinical trial material labeling and distribution to the clinic.

Sandeep received his PhD in 1992 and since then has been involved with the development of small molecule and protein drugs via Parenteral delivery. He has been lead formulator for four launched products.

Sandeep is a Certified Regulatory Affairs Professional. He is active in AAPS and PDA where he has served as Chairman, Arden House Conference on “Parenteral Products: Integrating Science, Innovation and Patient Needs”; Co-Chair, AAPS/FDA/USP workshop on ‘Future Direction in Aseptic Processing’; and past Chair of Sterile Product Focus group. He teaches at couple of Universities. Sandeep recently co-edited ‘Pharmaceutical Dosage Forms: Parenteral Medications”. In addition, he has served as Steering Committee Member for the Handbook of Pharmaceutical Excipients.

LinkedIn: linkedin.com/in/sandeep-nema-5412942