We provide a total solution to Pharmaceutical Industry for projects from pre-formulation & Formulation studies to analytical development to bio equivalence studies and technical dossiers.
- Formulation development is aimed to deliver a robust, bio-equivalent product which reproducible in mass scale with the same efficiency is carried out by us considering several factors.
- Analytical Methods , Stability indicating are developed and validated as per ICH Guidelines
- Scale Up batches are manufactured at facilities which are EU GMP and or USFDA approved.
- Process Validation is performed on Regulatory / Submission Batches and thereafter on large scale Commercial batches.
- Bioequivalence studies are performed at CRO’s with excellent track record and with EU and US approvals.
- Dossiers are compiled into various formats as required by authorities including ectd ready format.
- QBD is an integral part of the development for US destined products for ANDA filing.
- Full support for registration process of the product to grant MA / ANDA.
- Commercial supply for products from approved facilities in the dossier.