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About BaysMartinConsulting LLC
Who We Support
- Biotech and pharmaceutical manufacturers preparing IND, NDA/ANDA, biologics, or combination products
- Medical device and diagnostics companies planning 510(k), PMA, EU MDR/IVDR submissions
- Clinical and CLIA laboratories scaling test menus or expanding into new markets.
How We Help
Service Pillars
BMC is specialized in areas and will collaborate together to provide clients with comprehensive solutions that meet their unique product goals for successful global submissions.
Quality & Compliance Systems
CMC & Technical Documentation
Regulatory Strategy & Submissions
- Global submission Files: CTD, eCTD, STED, eSTAR, EU MDR/IVDR, UK, Japan, China, India, Africa.
- US drug & biologic products: IND, NDA/ANDA, biologics, OTC and generic products.
- Medical & combination devices: 510(k), PMA, combination products, companion diagnostics (CDx), OTC devices, veterinary devices.
- Agency interactions: Q‑Sub/Pre‑Sub, Type A/B meetings, health authority responses, CMS reimbursement strategy.
Research and Development in Biotechnology
BaysMartin Consulting is Federal, State, and city registered and certified to specific North American Industry Classification System (NAICS) codes. The following is a snapshot of what BMC can offer cross-functional Regulatory guidance for R&D Initiatives:
- Small molecule diagnostics programs from target validation, proof of concept in humans, to commercialization.
- Drug discovery and development including biochemistry, molecular biology, and analytical techniques, pharmacokinetics and Pharmacodynamics PCR, NGS, Immunoassays.
- Develop and optimize IVD assays for detecting trace concentrations of substances (e.g., proteins, DNA) with high accuracy, sensitivity, and specificity, reproducibility, and robustness following FDA standards and guidance such as CLSI guidelines and ICH/IMDRF testing models, including protein expression, purification, and formulation data.
Click to locate BMC Capabilities Statement with applicable NAICS Codes
Laboratory Compliance Services
BMC Experts have current HT (ASCP) licensure and brings extensive experience in laboratory management, supervision, and advanced histology techniques. In previous roles, BMC has successfully overseen daily lab operations, ensuring efficient workflows, quality output, and compliance with institutional and regulatory standards. BMC staff has supervised and trained diverse personnel, including histotechnologists and technicians, while managing lab resources, equipment, and budgets to optimize costs without compromising standards.
Our Approach
At BaysMartinConsulting LLC, collaboration is key to success. BaysMartin Consulting, LLC (BMC) envisions a future where strategic partnerships and collaborative innovation are key drivers of growth and industry impact. To further solidify its position as a leading consulting firm in the biotech and pharmaceutical sectors, BMC plans to build strategic partnerships with biotech manufacturers , Colleges and Universities to enhance product design, development, and regulatory compliance processes.
Apostille & Global Notary Services
Document services: Through our partner, Signature Notary Service, we provide apostille and notarization for documents used in global submissions to accompany product Dossiers.
Visit www.signaturenotaryservice.net to select your applicable service offering.
Contact Us
BaysMartin Consulting, LLC
email: Regulatory@BaysMartinConsulting.com phone: 866-672-3280
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