regulatory strategy and submissions

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.

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

Guosa Life Sciences is an integrated clinical development enterprise and the Network Coordinating Center of the Clinical Development Network. It helps sponsors, biotechnology companies, governments, academic institutions and global health organizations accelerate development of innovative medicines through four integrated platforms: GLS Institute, GLS Academy, the Clinical Development Network and Solutions. It operates across the US, Sub-Saharan Africa, Asia, Europe and MENA, with 35+ countries of reach and 60+ research-ready sites.

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biomarker analysisbiospecimen managementCapacity developmentclinical developmentcold chain logisticsGCP audits and inspection readinessIMP distributionPharmacovigilancestatistical analysis