Boston Biotech Consultants was founded in 1996 to serve the technical, financial & management needs of the Biopharmaceutical and Bioprocessing Community. It's mission is to provide the highest quality consultation, oversight or direction in all of the technical, financial & managerial aspects of Bioprocessing from discovery Intellectual Property issues to planning, forecasting, execution, technical transfer, scale up, contracts , cGMP manufacturing in house or at Contract Manufacturing Organizations, validations, site inspections, processs and assay troubleshooting as needed. Financial analysis, forecasting, mergers & acquisitions, financial management through net present value and ROI modelling.

We will assess your needs and focus the right experts at the right time to meet your goals.  Your assured success is our success!

• Review of discovery inventions, Intellectual Property assessments, Patents, Trade Secrets and freedom to operate/patent infringement reviews.
• 13th Annual "Buyer"s Guide to the cGMP Contract Manufacturers (CMOs) in the USA, Europe & Asia 2010"is in preparation. Order your copy now.
• Contract manufacturing "Man in the Plant" oversight services.
• 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. BARDA.
• Vaccine development & manufacturing.