Outsourcing and Implementation
Pharmakey utilizes in-house an extensive network of contract resources to bring custom-fit pharmaceutical solutions to each project. Our contractor network has proven quality across the spectrum of APIs and drug-products.
Steps in the Pharmakey Approach
Analysis of project needs and project scope
Draft Project Plan
Selection of contract companies
- Evaluation of US, European, Indian, and Chinese companies
- Technical and Quality consideration
Contract negotiation
Quality Audits
Project management services
Technical Interactions and Document Management
Final Deliverables Management
- Data and Statistics
- Document and Report management
- Supply Storage and Shipping
Outsourcing Capabilities
API Characterization and Manufacturing
Drug Product Development: preformulation through registration batch manufacturing
Analytical and Microbiology
Compendial Testing
Excipient Sourcing and Release
cGMP Manufacturing
Clinical Supply management
Preclinical site evaluation/selection
- Project Management
- Onsite Monitoring
- Product Supply and Shipping