Pharmaceutical development services including turn-key solutions for product realization, from conception to submission.
Our competitive advantages include:
- Wide formulation expertise ranging from conventional dosage forms to advanced technology platforms
- QbD based formulation and process development assured compliance with the current ICH Q8 guideline and trouble free scale up and technology transfer
- End to end product development including CMO identification and tech transfer activities
- Stand-alone activities such as feasibility studies, trouble-shooting (and tech transfer of existing products), consultation and identification of Freedom To Operate (FTO) in cooperation with client’s IP Dpt.
- Genepharm’s analytical R&D offers a wide range of service including
- Development of analytical methods, QbD approach upon request
- Analytical Method validation as per ICH guidelines
- Method transfer procedures to and from external laboratories
- Analytical support of formulation development
- Support of process validation and evaluation activities
- Stability testing in zones I-IV
- IVIVC studies upon request through co-operating parties