Our staff has extensive experience in Pharmaceutical Development and Technical Regulatory Requirements
Key offerings:- Formulation and process evaluation
- Manufacturing contractor evaluations and pre-qualification audits
- Small molecule synthesis to macromolecule bio-processing
- Experienced with solid oral dosage forms, solutions, injectables, suspensions, aerosols, and transdermals
- Analytical and Bioanalytical method development and review
- Validation plans
- IQ/OQ of equipment
- Standard Operating Procedures (SOPs)