Global
Regulatory Affairs
Innovative Regulatory strategies that position your Pharma, Medical Devices and Biotechnology business for success.
About BaysMartinConsulting LLC
Our Goals
BaysMartin Consulting, LLC (BMC) aims to be the premier consulting partner for biotech, pharmaceutical, and medical device companies seeking regulatory expertise, clinical trial support, and quality system implementation. BMC's goal is to empower clients to bring innovative, safe, and effective products to market efficiently and compliantly, continuously expanding our service offerings and client base. At BMC, the priority is to help businesses succeed with their regulatory needs. BaysMartin Consulting, strives to uphold a passion and commitment to excellence.
Regulatory Affairs Submission Services
BaysMartin Consulting offers a variety of consulting services including Regulatory, Clinical Affairs, and Quality Affairs. US and Global applications for product Dossiers, CTDs, eSTAR, STED, 510(k), PMA, IND, ANDA, Generics, Biologics, OTC Drugs / OTC Devices, Combination Devices, Veterinary devices, CDx, CLIA Laboratory, EU MDR / IVDR, UK Brexit, MDSAP, JPMDA, China, India, Africa, CMS Reimbursement, Q-Sub/Pre-sub strategies, Type A, B, meetings, Chemistry, Manufacturing, and Controls (CMC), pharmacology / toxicology, clinical, statistical, and more.
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.
Research and Development in Biotechnology
BaysMartin Consulting is certified to applicable 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
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 & General Notary Services
BaysMartin Consulting now partners with Signature Notary Service to offer a variety of Public Notary products including Apostille for use in Global submissions to accompany product Dossiers.
Visit www.signaturenotaryservice.net to select your applicable service offering.
Snapshot
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BaysMartin Consulting, LLC
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