58045-41-3 99%

Pharma-CRO Limited undertakes contract formulation development of Generic (Prescription & OTC), NCEs and proof of concept products (505(b)2 & Hybrid) of various dosage forms, aided by state-of-the-art technology and equipment. Formulation designs include: To develop proof of concept and create position by proactively patenting technology; Ethical Products; Veterinary Products; Efficient Project Management; To develop non-infringing (NIF) strategies, patent drafting, filing and coordinating with IP agents and attorneys.

Scope of Work: Literature Information & Primary Patent Status Evaluation landscaping and development strategy; Prototype Formulation Development in compliance with latest regulatory guidance such as ICH Q8 QbD; Packaging Development; Scale-up of selected Prototype Formulation; Process Optimization through QbD (ICH Q8); Process Validation; Manufacture of Exhibit/Bio-batch; Bioequivalence Study; Product Development Report; Documentation in CTD Format; Technology Transfer; Stability Study.