Quality & Regulatory Services Provided by Superlative BioSciences
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Compliance to FDA, EU, and ICH GLP, GMP, QSR, GTP, GCP; Eligibility for FDA Regenerative Medicine Advanced Therapy (RMAT) Designation;CE Marking Services; and ISO Documents Management.
This includes the Preparation of Quality Manuals & Other Quality Documents including Change Control, Deviations, Trending, CAPA, Root Cause Analysis, Complaint Handling, and Risk Management Plans. We also write SOPS, Master Batch Records (MBRs), Validation Plans & Reports.
We also prepare IRBs, Clinical Protocols, CMCs, INDs, BLAs, NDAs, 510Ks, PMAs documents and handle your company's FDA regulatory submissions.
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