Services

Regulatory Services

We can help with your regulatory strategy, no matter what market you work in. Our Regulatory strategy team have deep capabilities required to complement your in-house team and deliver strategies to support the successful commercialization of products portfolios. We have work closely with all Regulatory agencies over many years – That allow our clients to flexibly approach any market and confidentially comply with regulations.

We regularly help clients develop and implement strategies for following activities:

  • Global Regulatory support.
  • DMF compilation and review.
  • Regulatory Affairs and CMC strategic guidance.
    (e.g. Labeling, clinical trials, BA/BE study monitoring and protocol design, Stability studies, Launch planning)
  • Module writing 2.4-2.7 for all markets.
  • Dossier compilation and review for Global market. (USA, Europe and others)
  • New product development strategy and filing strategy.
  • eCTD support and online Dossier filing to MOH.
  • EU and USA local agent and office support.
  • IPR Support with strategy.
  • Gap analysis and due diligence of Dossier for Merger and acquisitions related regulatory issues.
  • GMP Audits. (API & FDF GMP sites Audits)
  • User testing activities for EU submission.
  • SOPs preparation and QMS set-up.
  • Deficiency response drafting and submission in eCTD.
  • Support in product life-cycle management from development to launch activity.
  • ANDA/NDA/MAA site transfer activity and alternate vendor filing strategy.