FDA Regulatory Affairs Biotechnology Consultants

Consulting Services

Biotech Consultant LLC

FDA Regulatory Affairs Biotechnology Consultants

> Regulatory Affairs Strategy Development

> FDA Submissions:

Investigational New Drug Applications (INDs)

New Drug Applications (NDAs)

     510(k)s

     Investigational Device Exemptions (IDEs)

     Pre-Market Approval (PMA)

> Analyte Specific Reagent (ASR) Regulatory Compliance

> FDA Registered U.S. Agent for Foreign Manufacturers

> Training Programs/Seminars/Distance Education

> Continuing Medical Education (CME) content development

> CPT Coding, Diagnostic Reimbursement issues

> Due Diligence

> HIPAA & CFR 21 Part 11 Compliance

> Quality Systems Compliance (QSRs, QA/QC, GMPs, SOPs)

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