CMC Pharmaceutical Development and Consulting Services
Pharmakey has the experience and on-demand resources to address technical challenges and regulatory requirements of pharmaceutical development: from small molecules, to proteins and cell-based therapeutics. We can assist in development of a broad range of dosage forms, including, tablet, topical, pulmonary, and parenteral products. Most of the staff and associates at Pharmakey have at least 20-years experience, and have executed numerous drug-development projects in support of new and active INDs. We have navigated the regulatory paths of multiple therapeutic areas. At Pharmakey, we know that careful selection and timing of pharmaceutical-development activities are key to achieving satisfactory bioavailability, mitigating risk, and meeting critical timelines.
Drug Substance Development
- API characterization
- Process Development and Scaling
- Analytical Methods Development and Validation
- Preformulation studies
- PreClinical and CTM Supplies
- Stability Testing
Drug Product Development
- Excipient Compatibility
- Formulation Development
- Analytical Methods
- Prototype Development
- Solid and Liquid Dosage Forms
- Oral, topical, inhaled, transdermal and parenteral
- Stability Testing
- Packaging and Labeling
- Product Development
- FDA Readiness
- Responses to FDA 483 observations and warning letters
- Pre-Approval Inspection (PAI) readiness
- Quality system evaluation and development
- Regulatory Requirements
- GMP/GLP Compliance
Due Diligence Consulting
Gap Analysis