BSB Consulting LLC

Providing scientific consulting services in pharmaceutical and medical device development with expertise spanning R&D, clinical strategy, and regulatory compliance. Specializing in oncology, immunology, fertility, and other therapeutic areas, with a proven track record of advancing innovative products ranging from antibody-based drug delivery to AI-driven medical imaging solutions in biopharma and medtech. Experienced in: - International regulatory strategy: USA (21 CFR, FD&C Act), Canada (MDR SOR/98-202), EU (MDD, MDR), UK (MDR 2002), Australia (TG(MD)R 2002), NZ (Medical Devices Regulations 2003), S/SE Asia (India, Singapore, & Malaysia MDR, Thai MDA) - Regulatory submissions: INDs, pre-INDs, 510ks, de novos, technical files, DHF, pre-submissions (Q-subs), SIR, orphan drug designation, expanded access - Clinical development: CEPs, CSPs (RCT, FIH, observational, etc.), CSRs, CERs, IRB submissions, PICFs, IBs, CTAs, MTAs - Scientific development: pre-clinical/nonclinical studies (PK, toxicity, human factors usability, reproducibility, etc.), peer-reviewed publications - Labelling & marketing: controlled claims, IFU, user guides, product labelling, brochures, websites - Post-market surveillance: PMS studies, PMCF, SSCP, AE classification & reporting, customer feedback, NCR/CAPA - Quality management: SOPs, WI, risk management & analysis, internal/external audits - Data protection compliance: GDPR, HIPAA, CCPA, PDPA, Australia/NZ Privacy Acts