Lachman Consultants Blog FDA Issues Notice to Pharmaceutical Companies Regarding the CRO Raptim Research Pvt. Ltd.

On March 28, the FDA issued a notice (here) informing pharmaceutical companies that have submitted in vitro and in vivo bioequivalence studies in applications that were conducted by Raptim Research Pvt. Ltd., a contract research organization (CRO) based in Navi Mumbai, India, that it has "identified significant data integrity and study conduct concerns" in certain studies in [...]The post FDA Issues Notice to Pharmaceutical Companies Regarding the CRO Raptim Research Pvt. Ltd. appeared first on Lachman Consultant Services, Inc..