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Formulation Development
Our formulation laboratories are fully equipped and GLP compliant, for the development of oral solids – tablets (IR and MR), capsules and pellets, liquid formulations and topical dosage forms. We operate a highly efficient development centre which provides streamlined pre-formulation, formulation, and analytical development and validation for our clients.
Analytical Development
We offer analytical development and validation as a standalone service in addition to our formulation development activities. Our dedicated teams of scientists and scientific personnel are integrated with pre-formulation, product development and quality assurance teams to ensure efficient product development.
Technology Transfer
Our specialized team of scientists and scientific personnel conducts a complete transfer of all technology post-development for a product, to our clients’ designated manufacturing sites around the world. We advise, supervise and facilitate a smooth transition of product infrastructure from R&D to manufacturing, along with associated analytical, regulatory and documentation support until commercial readiness. Our clients benefit from our conducive, privileged partnerships with Contract Manufacturing Organizations (CMOs) which are US-FDA, EU-GMP and PICs approved.
R&D SUPPORT SOLUTIONS
We supplement our core R&D functions with market-specific regulatory support, intellectual property landscaping and strategy solutions, quality control support, and analytical support for specific markets. We provide these solutions to our clients by virtue of our privileged partnerships with companies in these respective fields.
CLINICAL RESEARCH SUPPORT
Our clients receive support for clinical testing, owing to our partnership with an experienced Clinical Research Organization (CRO), specifically with respect to bioavailability and bioequivalence studies. Our CRO partner specializes in handling a complex and highly differentiated spectrum of generics.
Regulatory Services
All the development at Epione is strongly facilitated by regulatory affairs and urge of quality at each step is covered. Our team has a core experience is the following aspects
- Documentation preparation as per e-CTD format.
- Review of protocols and reports.
- Stringent framework for SOPs
- Preparation, review and submission of ANDA, Dossier etc.
Quality Assurance
Epione has strong relationship with US-FDA, EU-GMP, PICs approved CMOs. All the validation activities are performed at the CMO in presence of the core team. Epione is capable for finding a suitable CMO partner based on the need of the sponsor and the molecule.