Pharmaceuticals - Laguna Beach, California, United States
A Pharmaceutical consulting group with expertise in establishing Total quality system to meeing regulatory reqirements for drug development, manufacturing API and drug products (USFDA, EMA, NMPA, Health Canada, TGA). Expert in preparation and review of CMC section and APR, GAP analysis, we provide building GMP culture, preparing SOPs. protocols, reports, development and validation of analytical methods, and qualification of buildings, equipment and instruments. We also give in depth training with appropriate documentation.