SRK Consulting provides comprehensive Chemistry, Manufacturing and Controls (CMC) regulatory services to the pharmaceutical, device and biotech industries. We provide a range of regulatory and technical services. These include the development and implementation of CMC development programs incorporating strategic planning and integration of CMC development plans with toxicology and clinical development requirements. We assist in the preparation and/or review of regulatory submissions (IND, NDA, ANDA, PLA, DMF, IDE, PMA), participate in GXP compliance audits and manage and provide liaison with CMC contractors as a member of your project team.