3P Batch Review

Whether you need expert services for an independent batch release program or if you have a health authority commitment as part of an inspection outcome or Warning Letter mandatory need for independent third-party batch review and release, count on our excellent expertise team, which has decades of experience in batch review and release oversight into many developed markets. We have an experienced team well versed with the regulatory requirements and health authority expectations globally. We have helped firms to meet their commitments to the USFDA and HC. We have several QPs on board to help with the EU market. We can perform GMP batch review and release for all the DS and DP for sterile, non-sterile, and biological medicinal products. We can also help you with a similar exercise for Oral Solids and Pharmaceutical Ingredients.