Pharmaceutical development services including turn-key solutions for product realization, from conception to submission. 

Our competitive advantages include:

1. 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.
   
   
   
2. 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

Genepharm, having wide and significant experience in the regulatory affairs domain within EU and global markets, can guide your candidate product through successful submission, offering Regulatory services including:

1. evaluation of scientific and technical data and guidance through development
2. dossier compilation (including eCTD sequences)
3. submission via DCP/MRP
4. maintenance of marketing authorizations within EU (renewals, variations)
5. liaison with competent authorities and keeping abreast of relevant legislation