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Capability

CMC and technical documentation

Suppliers
1
States & provinces
1
Countries
1

1 cmc and technical documentation supplier across 1 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

BaysMartin Consulting, LLC (BMC) is a consulting firm providing strategic regulatory, quality, and clinical consulting for diagnostics, medical device, pharmaceutical, biologics, and emerging healthcare technology companies. BMC supports clients with global submissions, quality and compliance systems, CMC and technical documentation, regulatory strategy, laboratory compliance services, and audit and recall services.

agency interactions (Q-Sub/Pre-Sub, Type A/B meetings)Auditing servicesglobal submission files (CTD, eCTD, STED, eSTAR, EU MDR/IVDR)histology techniquesIVD assay development and optimizationlaboratory compliance servicesPCR, NGS, immunoassaysquality and compliance systemsrecall managementregulatory strategy and submissionstraining and workshops

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