Mark Formulations Pvt. Ltd.
"Over +25 years of experience in Generic Product development for US, Europe and other regulated market. Sound knowledge of Intellectual Property Rights (IPR) and Product Development using Quality-by-Design(QbD) concepts. Expertise in Product Development, Process Development, Process Optimization, Process Scale-up, Process Validation and Technology Transfer. Good understanding and knowledge of pharmacokinetics and in-vitro dissolution, specially with respect to Bioequivalence Studies. Demonstrated project management skills. Good understanding of regulatory requirements, cGMP & Compliance for US and other Regulated markets. Established team building and leadership skills for big teams. Good problem solving skills. "