Topical Drug Products
- Development of detailed CMC product development plans (from early phase development all the way to final regulatory submission, approval and commercialization),
- Includes creams, ointments, lotions, gels, suppositories and patches.
- Pre-formulation and formulation development (including preservative evaluation, selection and testing)
- Container-closure and package evaluation, selection & testing
- Analytical and microbiological development
- Stability testing as per ICH guidelines.
- GMP compliance for clinical and commercial manufacturing
- Scale-up; process development and validation
- QC product release.
- Technical documentation
STM PHARMA CONSULTING, LLC
Wilmington, Delaware
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