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Regulatory Affairs
We approach our responsibilities in regulatory submissions and medical writing with a dedicated and serious commitment, ensuring the meticulous and efficient central management of the submission process.
Recognizing regulatory submissions as among the pivotal milestones in a clinical research program, we understand their crucial role in expediting time to market. By facilitating swift regulatory approvals, we aim to bring the advantages of new treatments to patients sooner, thereby maximizing the impact of research investments and enhancing patient lives. Our steadfast dedication to the regulatory process reflects our commitment to advancing healthcare outcomes and optimizing the overall success of clinical research initiatives.
Regulatory Services
- Regulatory advice – developing a robust Regional / International Regulatory strategy
- Preparation of dossiers for national Competent Authorities and /or accredited Medical Ethical Research Committees (IRBs)
- Submission of dossiers for national Competent Authorities and /or accredited Medical Ethical Research Committees
- Dossier compilation as per DCGI, Asian Common Technical Dossier (ACTD) Guidelines, Common Technical Dossier (CTD) Guidelines, Drug Master File (DMF)
