Your Product Development Challenges Are My Passion!
Specialty Areas:
- Pre-clinical & clinical stage biologics programs
- General CMC strategy, development, and management
- Downstream process development, scale-up, tech transfer, cGMP manufacturing
Services:
- Hourly contract or interim/part-time FTE support
- Senior/executive level CMC strategy and operational support
- General CMC guidance (cell line, analytical, and process, development; product characterization and stability)
- CMC gap and risk assessments/mitigation strategies and change impact assessments
- Early biologic program (protein/antibody & CGT) technical In/Out-licensing due diligence
- CDMO selection, alliance management, tech transfer, and audit support
- CMC Pre-IND & IND filings and regulatory support
- Building in-house CMC capabilities (lab facilities & team)
- Technical writing (SOPs, batch records, reports, grant/contract applications)
- Downstream manufacturing deviations and failure investigations and resolution support
- Green & brownfield manufacturing facility downstream bioprocess engineering support (design/build/start-up/validation)
Company Details
- Founded
- -
- Address
- Rockville, Maryland, Us
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Keywords
- Biotherapeutics, R&D, Preclinical, IND Enabling, Early Clinical, Antibody and Recombinant Proteins, CGT, CMC Strategy, CMC Development, Process Development, Downstream Process Engineering, Process Optimization and Scale-up, Technology Transfer, CDMO Alliance Management, Technical Audit Support, CMC Regulatory Support, IND CMC Filings, Scientific & Technical Due Diligence, Technical Writing, Failure Investigations and Resolution, and Manufacturing Facility Design, Build, Start-up Process Engineering Support.
- HQ
- Rockville, Maryland
- Competitors
- Forbion.
Amvance Consulting, Llc Questions
Amvance Consulting, Llc's LinkedIn profile is https://www.linkedin.com/company/amvance
Amvance Consulting, Llc's industry is
Biotechnology Research
Amvance Consulting, Llc's top competitors are
Forbion.
Amvance Consulting, Llc's categories are Biotechnology Research
Amvance Consulting, Llc's founding year is 2023
