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
Company Details
- Employees
- 1
- Founded
- -
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
Bsb Consulting Llc Questions
Bsb Consulting Llc's LinkedIn profile is https://www.linkedin.com/company/bsb-consulting-llc
Bsb Consulting Llc has
1 employees.
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employees at Bsb Consulting Llc.
Bsb Consulting Llc's industry is
Business Consulting and Services
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Bsb Consulting Llc's categories are Business Consulting and Services
Bsb Consulting Llc's founding year is 2024
