Regulatory Consultation
You can rely on our practical knowledge in the India and International regulatory arenas through all phases of the drug-development process.
We offer extensive industry experience shaping project plans to meet diverse regulatory requirements.
Our experts strategize the most efficient route for your product, from bioanalytical study requirements, and applications to Competent Authorities and Ethics Committees, to successful marketing applications, while providing the necessary guidance to ensure continual regulatory compliance.
We remain current with regional regulatory requirements as they evolve. Our proactive approach and careful counselling ensure that there are no surprises.
We offer:
- Insight on local regulatory environments.
- Smooth transitions from exploratory to confirmatory stages of investigational drugs.
- Expedited submissions for possible acceleration of the developmental process.
- Facilitated approval of applications to conduct clinical trials of new drugs.
- Responses to regulatory body requests for information.
- Support for and participation in meetings with regulatory bodies.
- we provide crucial links to major regulatory authorities and are skilled in the preparation, coordination, and management of complex multinational submissions and meetings.