Ramesh Shingala Email & Phone Number

Formulation development scientist with more than 15 years of experience in formulation development and technology transfer from concept to completion in reputed mid to large India pharmaceutical organizationsSpecialties & Key Skills* Hands-on experience in formulation development of complex oral solid products for US, Europe, Canada and Brazil;* 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;* Sound knowledge of pharmacokinetics and in-vitro dissolution especially with respect to BE Studies;* Understanding of regulatory requirements, cGMP & Compliance for US, Europe, Canada and Brazil;* Expertise in formulation development of P-IV and NCE-1 projects with stringent project timelines;* Strong collaboration skills with supporting functions like API Development, Analytical Development, IP, Technology Transfer Groups, Manufacturing and Regulatory Affairs;* Sound understanding of CMC and CTD sections of regulatory submissions such as IND, 505(b)(2) NDA, ANDA, MAA to FDA/EMEA; & pre-approval inspections

Listed skills include Regulatory Affairs, Drug Delivery, Anda, Formulation, and 1 others.

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  Rajiv Gandhi University Of Health Sciences

  Pharmaceutics