Our Consulting Services
- CMC function leadership
- Project planning and budgeting
- Contract Development Organization selection
- Strategy for integration of CMC, clinical and non-clinical development
- Solve development problems with phase-appropriate solutions
- Pharmaceutical Product Development
- Develop drug substance and drug product, including analytical methods
- Deliver clinical supplies to the project team
- Author and review regulatory documents
- Regulatory advice and services
- FDA interactions
- Regulatory submissions
- Submissions strategy
- SOP authoring and review
- Sourcing and oversight of synthetic, analytical, and formulation development
- Vendor selection, GMP auditing, and management
- Method development
- Synthetic process development
- Formulation development
- Stability studies
- Analytical development
- Method development (development phase-appropriate)
- Method trouble-shooting
- Validation protocols
- Stability protocols, data review and organizing
- Method transfer protocols and oversight
- Formulation development
- Evaluation of preclinical data
- Evaluation of biopharmaceutical properties and BCS category
- Selection of absorption enhancement technology
- Select formulation platform based on dose, physical properties, and PK/PD
- Quality Assurance and Control functions
- GMP auditing of contract development organizations
- Certificate of Analysis review
- Batch record review
- Auditing of contract development organizations
- GMP compliance
- OOS and quality investigations
- Review of SOP’s, record-keeping, and training documentation
- Authoring and reviewing regulatory documents
- Organize and review analytical data, batch records and process descriptions
- Produce modules or integrated regulatory documents
- Review modules and integrate comments into a consensus document
- Deliver regulatory documentation for print or electronic submissions
- Review complete CMC regulatory submissions and identify gaps
- Due diligence and drug candidate evaluation
- On-site visits and document review
- Drug candidate evaluation reports (CMC area)
- Representation to potential partners
- Consultation on intellectual property
- US Agent for foreign DMF holders
- DMF submissions to FDA
- Liaison for FDA contact and correspondence
- Regulatory advice
- Document authoring and review
- Organizational development in the CMC area
- CMC staff development
- Development and delivery of training for CMC staff
- Manufacturing Strategy
- Supply chain management
- Site selection
- Lifecycle planning
- Japanese topics in pharmaceutical development
- CMC aspects of drug development for the Japanese market
- Bio-equivalence requirements in drug development
- Collaboration with Japanese development
- Differences in drug development between Japan and ROW
- Working practices
- Cultural training
- Due diligence with Japanese partners