Regulatory
Our regulatory affairs team is familiar with the regulatory process for IND, ANDA and DMF filing.We can help you facilitate your project to approval and market in USA.The group offers clients a staff of CMC experts having a wide range of experience coming from large and small pharma.In addition, the science-based staff has first-hand CMC knowledge and experience in preformulation, formulation development, analytical development, quality assurance, pharmaceutical manufacturing and project management.

We offer Regulatory strategy consultation and guidance CMC submission writing, organization, quality review and filing Meeting management including scientific advice requests, materials, preparation and follow-up CMC submission critique and assessment Project management