With over 50 years of combined expertise in the areas of physical pharmacy and pharmaceutics,
we can assist you in providing a realistic insight into your API’s quickest pathway to a successful
pharmaceutical dosage form. We have in-house capabilities to perform almost all kinds of studies
including pH-solubility and stability profiles; particle size characterization and effects on solubility
enhancement; excipient and vehicle compatibility screening and recommendations.
Studies are designed to establish a sound and complete understanding of the entitie’s physico-chemical
characteristics and provide a basis for efficient, rational formulation development
- Raw material and Drug Substance characterization
- Drug-Excipient interactions
- Formulation optimization and process development/validation
- Packaging-Container closure compatibility studies
- Stability Studies (including ICH guidelines and specifications)
- Specialized dosage form development such as controlled release drug delivery systems, liposomes, microencapsulation and biodegradable depot implants (microspheres), topical gels and transdermal drug delivery systems, micro and nano-emulsions, sterile injectable dosage forms as well as all kinds of
solid oral formulations
- Complete regulatory and documentation support for FDA regulatory submissions including CMC, NDAs and ANDAs.