Regulatory Affairs

  • Product Development
  • Formulation Development
  • API Development
  • Regulatory Affairs
  • Quality management & Audits

Formulation Development

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. chart

  • 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.

API Development

We have experience in contract development of Active ingredients. To achieve complete backward integration for our customers, certain critical Active substances are developed by ourselves and further contract manufactured in certain complaint manufacturing facilities. We undertake responsibility right from the development activity of the active substance, sourcing of the intermediates, finalizing route of Synthesis, lab trials, stability, method validations, exhibit batches manufacturing at contracted locations, preparation of Drug master files, up to receipt of a Certificate of Suitability or a US Drug Master File as the case maybe. We have successfully developed a few molecules for our customers on exclusive basis.

Regulatory Affairs

The overall activities are of regulatory affairs are to obtain Marketing Authorization’s for generic products. We support the entire drug approval process which involves;

  • Preparation of Drug Master Files in CTD format and Technical Dossiers including finished product dossiers in e-ctd format.
  • Support for marketing authorisation applications.
  • Answering of deficiency letters.
  • Maintenance, support and optimisation of your marketing authorisations.
  • National variations and EU variation procedures.

Quality management

We ensure that we provide the products complying with international standards and of best QUALITY as per Europe & USFDA guidelines. Audits: Periodic audits of API manufacturing sites being preferred by agencies in lieu of a complaint GMP certificate, the need for outsourcing audits has been ever increasing. We have expert auditors having audited several facilities in India. We undertake Active substance audit services for our customers for those manufacturing formulations with the active substances from manufacturing sites which are not inspected by any EU authority. That being said, I location of caller cell phone find more and more often that I go into bookstores and leave empty handed. Audit reports are confidential and client specific apart from our own in house audits.