Good Manufacturing Practice (GMP)

We provide specialized services in Good Manufacturing Practice (GMP) to ensure that products are consistently produced and controlled according to quality standards.
Good Clinical Practice (GCP)

Clinical Operations Selection of CRO Vendor Oversight GCP Auditing (FDA and ICH GCP) Investigator Site Audits Phase 1 Facility Audits Clinical Vendor Audits (CROs) Mock Inspections Essential Documents and Trial Master File (TMF) Audits Electronic Trial Master File (eTMF) Audits Clinical Trial Audits
Chemistry and Manufacturing Controls (CMC)

Our CMC services focus on providing support on selection of Drug Substance and Drug Product suppliers such as CDMOs and CTOs, manufacturing process, including testing methods, specifications and compliance with applicable ICH guidance.