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YOUR PRODUCT DEVELOPMENT PARTNERS
- We provide biotechnology companies with expert guidance and assistance in product development
- Our expertise in development strategy, scientific design, implementation, and management of your company's programs ensures that we meet all regulatory requirements throughout the drug development process
- We do this by becoming an integral part of your internal project team. We can champion your program, providing leadership and focus, or support you in the management of operations, both on site and virtual, to accommodate your growing needs, or if necessary
- We can select and manage other contract organizations to ensure the success of your development programs
SERVICES WE PROVIDE
- Strategic Planning
- Integrated development plans incorporating non-clinical, clinical and regulatory strategies
- Global strategies to optimize development timelines and commercial value
- Identify product strengths and weaknesses (i.e. risk assessment) to leverage expedited development pathways and contingency plans
- Project management functions to ensure timely and quality execution of development plans
- Regulatory Expertise
- FDA Liaison
- Preparation of regulatory submissions including pre-IND meeting packages, IND, BLA, NDA, and related supplements/amendments
- Report writing
- Investigator Brochures
- Orphan Drug and Fast Track Applications
- Toxicology
- Design IND enabling toxicology program
- Identify GLP Contract Organization
- Monitor conduct of studies
- Preparation of final reports and IND summaries
- Clinical Research
- Clin/reg strategy
- Protocol development
- Clinical study implementation including site selection and management
- Clinical documentation
- DSMB establishment
- Medical Monitoring
- Clinical advisory board establishment
- Clinical labs and data management
- Trial tracking
- Quality Programs
- Quality Assurance Operations and Audits
- Documentation system development
- cGMP Training
- Validation Services
- Quality Control Services
- Product testing
- Stability programs
- Assay development/validation
- CMC (biologics and drugs)
- Development strategy
- Vendor selection and management
- Technical transfer
- Specification review
- Manufacturing documentation development and review
- Facilities audits
- Process development review
- Scientific and technical support
For more details and a confidential discussion of how we can aid your enterprise, please call:
Stein Consulting
858.523.9215
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