With 20+ years of experience in pharmaceutical development and regulatory strategy, Dr. Kulkarni founded the firm to support pharmaceutical and life science organizations in bringing high-quality medicines/treatments to market efficiently and compliantly.
Dr. Kulkarni specializes in complex non-sterile dosage forms, including semi-solid, liquid and nasal spray drug products, and provides scientific and strategic consulting across formulation development, regulatory pathways, and product lifecycle management.
Throughout his career in the CDMO industry, Dr. Kulkarni has contributed across multiple product development functions, including Regulatory Affairs, CMC, Quality, Supply Chain, and Packaging Engineering, gaining deep expertise in developing complex generic and innovative drug products from concept to manufacturing.
His specialty is in the niche market of topical and intranasal medications. His expertise include:
- Design & development of drug delivery systems including liposomes, lipid emulsions using manufacturable processes.
- Semi-solid topical formulations (Creams, Gels, Lotions, Ointments).
- Pharmaceutical liquids, suspensions and topical spray drug products.
- Combinatorial drug products including nasal spray drug delivery systems
Dr. Kulkarni works closely with clients to navigate complex formulation and regulatory challenges, helping bring products to market more efficiently. He specializes in lipid-based systems, with deep technical knowledge of lipids, surfactants, microstructures, particle size optimization, and microfluidization processes.
He has a strong track record of developing and characterizing formulations in alignment with CMC requirements and Product-Specific Guidance (PSG) for ANDA submissions. His experience spans the comprehensive characterization of drug substances, drug products, and excipients using advanced analytical techniques, including HPLC, particle size analysis, rheology, droplet sizing, spray pattern and plume geometry evaluation, optical microscopy, SEM/TEM, DSC, TGA, and XRPD.
Dr. Kulkarni’s scientific rigor, and practical experience in integrated and full drug product development, that is complete with insights on API & Excipient selection, Regulatory, GMP, and Quality compliance, experience with container-closure systems, and supply chain concerns makes him a well-rounded leader with holistic approach in drug product development.
Dr. Kulkarni is a well-published scientist and thought leader, with books, book chapters, research articles in peer-reviewed scientific journals and patents. He has Ph.D. in Physical Chemistry, specialization in Surface/Interfacial and Surfactant Chemistry and has US Pharmaceutical Regulatory Affairs Certification.