CMC Tech, LLC is a BioPharmaceutical consulting company specializing in CMC development and manufacturing, spanning phase 1 through commercial products:
Startups:
• Process development and manufacturing strategy
- Phase 1 clinical through commercial manufacturing
- Strategy planning and execution leadership for development and
manufacturing
- Internal and/or external CDMO engagement and management
- Identification of CDMOs
• Regulatory strategy for CMC sections
- Strategy creation and management
- Technical writing contractor identification
• CMC execution leadership for companies that do not require a full-time
CMC leader
• Audit of CDMO manufacturing and quality systems
• Extensive Consultant network to assist you in finding the experts you need
Small pharma:
• Services listed above for start-ups that are tailored to your unique company
needs, plus
• CMC execution leadership
- Fill temporary gaps during a talent search
- Companies that only require a full-time CMC or project leader
Multinationals:
• Due diligence and audit services
- Product acquisition or divestment
- Independent voice during negotiations
• CMC strategy and execution
• Contractor engagement and management
• Extensive Consultant network to assist you in finding the experts you need
Venture Capital and Private Equity Investor Services:
• Audit services of company R&D, manufacturing, CMC regulatory and quality
systems
- Documentation and/or on-site audits
- Assessment of the company’s internal capabilities and potential gaps
- Assessment of the company’s external partners and potential gaps
- Product/process risk mapping
• CMC strategy services
- Strategy planning and execution
- Strategy & resource gap assessment
- Risk reduction mapping and remediation recommendations & resources
- CMC execution leadership
Company Details
- Founded
- -
- Address
- 51 Hartz St, Gloucester,massachusetts 01930,united States
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- http://www.CMCTechLLC.com
- Keywords
- Consulting, Pharmaceutical, BioPharmaceutical, CMC, Strategy, Leadership, Venture Capital, Private Investors, Start-Ups, Manufacturing, Development, CDMO, Solid Dosage, Ophthalmic, Vaccine, Sterile, Regulatory, FDA, Clinical Manufacturing, Commercial Manufacturing, GMP, Hot Melt Extrusion, packaging, combination products, Clinical Phase, Tablets, Capsules, Syringes, Lyophilization, Biologic.
- HQ
- Gloucester, Massachusetts
Cmc Tech, Llc Questions
Cmc Tech, Llc's website is http://www.CMCTechLLC.com
Cmc Tech, Llc's LinkedIn profile is https://www.linkedin.com/company/cmc-tech-llc
Cmc Tech, Llc's industry is
Pharmaceutical Manufacturing
Cmc Tech, Llc's top competitors are
Gmptraining.com, Inc.,
Cmc Drug Product Consulting,
Compliance X Consulting,
Trubiotech,
Smart Pharmaceutical Consulting (Spc),
Grey Crow Regulatory Consulting, L.l.c.,
Fd-Aid, Llc,
The Sar Group, Llc,
Lenape Pharma Gmp Consulting, Llc,
Ayd Biopharma Consulting Group Llc.
Cmc Tech, Llc's categories are Pharmaceutical Manufacturing
Cmc Tech, Llc's founding year is 2022
