In consideration of the rapidly growing use of ASAPprime® (the Accelerated Stability Assessment Program) in regulatory filings, FreeThink now offers our pharmaceutical customers the service of regulatory document preparation to speed entry into clinical trials and to enable faster market introduction of new and generic drug products.
In addition to our existing supporting services for accelerated stability studies, including our ability to carry out ASAP experimental and modeling work for customers under full cGMP, FreeThink has added Pharma industry veteran Susan Berlam to the FreeThink team. Susan has >30 years of pharmaceutical industry experience as a skilled Regulatory Chemistry, Manufacturing and Controls (CMC) and Quality Assurance leader. In particular, she has vast experience preparing regulatory documents for all phases of drug development from IND/IMPD through NDA registration. With this addition, FreeThink can now support preparation of the applicable sections of regulatory filings from IND/IMPD through NDA/ANDA, to post-approval changes.