Services
Services provided by Pharmalytical Consulting LLC include the following:
- Rational, phase-appropriate interpretation and application of CMC regulatory requirements for API and drug product manufacturing, specifications, and testing methodologies
- Outsourcing support through contract site screening and selection, due diligence and contract negotiations for manufacturing and testing activities
- Oversite of contract manufacturers or testing laboratories including process, technology, and test method transfers, technical liaison, document generation, data review, and auditing
- Analytical method development/qualification/
validation/documentation for API and finished drug products - Stability study design, oversight, interpretation, and documentation
- Document generation including SOPs, specifications, test methods, protocols, technical reports, and comparability protocols
- CMC regulatory strategies and document generation including IND, amendments, annual reports, and NDAs
- Topical and parenteral formulation and method development
- All aspects of validation including master plans; equipment, facilities, and instrumentation IQ/OQ/PQs; and process, cleaning, and test methods
- CMC project management support including timeline and budget development.
- Process scale-up support including criticality assessments, robustness/yield improvement
- Documentation to establish laboratories as GMP or GLP compliance