Our Services
FR&D Services
PHARMULA provides complete range of services necessary for the customer to achieve their objectives of product development to commercial launch in the best possible / achievable timelines. A truly one stop solution for pharmaceutical formulation development for any market.
Galenic Development
Selection of Pharmaceutical form, compatibility studies on active substances and excipients, definition of qualitative and quantitative formula, design of the manufacturing method, establishment of process controls, transfer of Technology to the client.
Stability Studies
Pre-Stability studies during drug product development, studies performed as per ICH guidelines, in-use stability, photo stability and post marketing studies.
Regulatory Services
Compilation of the dossier for drug products following the eCTD format, CTD format, designation management of orphan drugs, investigational medicinal product dossier.
Analytical Development
Set up and validation of the analytical methods to control the active substances, its impurities and degradation products in the raw material and the final product, control of the manufacturing process, “in vitro” dissolution test, cleaning control, microbiological control.
Manufacturing of Pilot and Clinical Trial Batches
Our manufacturing partner’s facility complies with cGMP requirements for manufacturing injectable formulations
Comprehensive FR&D Services Under One Roof
PHARMULA is primarily engaged in the following business verticals. These business verticals are consciously selected to support the pharmaceutical industry’s key requirements and challenges.