Boston Biotech Consultants is proud to offer a broad and comprehensive range of Intellectual Property, financial, management, technical,cGMP Bioprocessing, oversight & troubleshooting Services:
- Vaccine development & manufacturing.
- Assistance with Health & Human Services BARDA medical countermeasures acquisition activities, process & presentations.
- 13th Annual "Buyer's Guide to the cGMP Contract Manufacturing Organizations in the USA, Europe & Asia 2010 Edition" now in preparation. Order your copy now.
- Contract manufacturing "Man in the Plant" oversight services.
- Financial analysis, financial forecasting, market research surveys, mergers and acquisitions, Net Present value and ROI modeling.
- Discovery inventions review, Intellectual Property assessments, Patents, Trade Secrets strategies and freedom to operate /Patent infringement reviews.
- Process development for microbial and cell culture formats.
- Process, assay & formulation troubleshooting.
- Upstream and downstream process development.
- Final formulation development.
- Scale up from plasticware to full commercial scale..
- Full scale manufacturing in house or at Contract Manufacturing Operators (CMOs).
- Assay development.
- Assay specifications.
- Assay transfer.
- Assay validations.
- Technical transfer to in house and CMO sites.
- CMO selection, negotiations and oversight.
- Validations.
- IND submissions.
- FDA face to face and telecon meetings.
- BLA and NDA submissions.
- Strategic assessments & management reviews.
- BioDefense Medical Countermeasure Biologics Therapeutics Medicines (HHS BARDA acquisitions).
