- Provide day-to-day technical, quality, regulatory and project management support throughout all phases of product development
- Offer technical and regulatory support to help you select the best expression system for your product and oversee cell line development and characterization
- Support cell and gene therapy development and manufacturing options
- Develop or optimize upstream, downstream processes, incorporating current industry best practices
- Recommend, implement, qualify and validate analytical methods for in-process control, product testing, and characterization
- Prepare or review CMC development plans and strategies to de-risk your program and accelerate product development and assess any technical and regulatory gaps necessary to meet your critical CMC milestones
- Identify, qualify, and manage contract manufacturers (CMOs) and other service providers for all modalities
- Offer CMC program and project management
- Develop and oversee process validation, characterization and comparability strategies
BDO will advise and assist with the quality, regulatory, and compliance requirements for your product and organization at all stages of product development and commercialization.
- Establish Quality Systems and Quality Manual
- Support and develop the Target Product Profile (TPP) and other key quality attributes
- Develop CMC regulatory strategies and risk profiles
- Write Module 3 and support FDA meetings relating to CMC
- Negotiate BLA package, rolling submissions
- Conduct cGXP compliance audits
- Review of IND and BLA applications and amendments
- Offer PAI readiness, responses to FDA 483 “For Cause” audits and consent decrees
Our CMC experts help you deliver quality drug material and the data required to support global regulatory filings throughout all stages of your product’s lifecycle:
- Develop a short and long term supply chain strategy
- Assist CMO choice, clinical and commercial supply agreement negotiations
- Oversee CMO operations and compliance matters
- Improve delivery time to clinic and customer
- Make (in-house) vs buy (outsource) analysis
- Cost of Goods Sold (COGS)
- Technical due diligence
- Manufacturing network design
- Looking for a CMO or looking to build?
- BPTG’s proprietary bioTRAK® database or bioTRAK® subscription can help you decide on the cost, time, and risks
- bioTRAK® uses public information on biopharma capacity
- Provides detailed information and analysis on the balance of supply & demand of biomanufacturing capacity
- Standard reports on macro/micro supply & demand
- Custom reports on biomanufacturing capacity
Our assessment professionals identify potential hurdles and risks. Using their industry knowledge, BPTG consultants provide the in-depth analyses you need to make sound strategic and financial investment decisions.
- Technology market assessments
- New product and supplier market assessments
- Technical and M&A due diligence
- Expert witness
- Process and economic modeling
Multinational Biopharmaceutical Companies
Early-Stage Biotechnology Companies
Cell and Gene Therapy Companies
CDMOs, CMOs, Laboratories and Suppliers
Investment Firms and Service Providers
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