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.