Regulatory Consulting
Regulatory success lies not only in compliance, but in anticipation.
End-to-End Regulatory Affairs and Compliance Solutions : We leverage strong India-based regulatory resources to seamlessly support pharmaceutical, biotechnology, and medical device regulatory requirements.
At Catalyst Clinical Services, our regulatory affairs experts combine deep domain knowledge with hands-on experience to navigate complex local and global regulatory landscapes with precision and foresight. We proactively identify regulatory requirements and anticipate submission-stage challenges, enabling sponsors to address concerns early and achieve timely, seamless approvals.
From early-phase planning through post-approval obligations, we provide end-to-end regulatory consulting and compliance support across the entire clinical trial lifecycle. Our integrated, risk-aware approach minimizes delays, mitigates regulatory uncertainty, and ensures alignment with evolving regulatory frameworks.
Regulatory Dossier Preparation
- Preparation of high-quality, submission-ready regulatory dossiers
- Compliance with NDCTR 2019, ICH-GCP guidelines, and applicable local requirements
- Review for completeness, accuracy, and regulatory consistency to support efficient approvals
Regulatory Authority Coordination
- Single point of contact for coordination with the Ministry of Health and Family Welfare (MoH) and regulatory authorities
- Support for clinical trial approvals, regulatory queries, and follow-up submissions
- Proactive engagement to facilitate timely regulatory decisions
Import License Management
- End-to-end coordination for issuance, amendment, and renewal of Import Licenses
- Coverage for investigational products, comparators, and trial-related materials
- Ensuring regulatory continuity and uninterrupted trial conduct
Safety Reporting & Pharmacovigilance
- Comprehensive safety reporting in accordance with Table 5, Third Schedule of NDCTR 2019
- Support for SUSAR reporting, periodic safety updates, and annual safety submissions
- Coordination with Ethics Committees and regulatory authorities to ensure timely compliance
Regulatory Documentation
- Collaboration between regulatory and medical writing teams
- Preparation of regulator-ready CSRs and supporting documentation
- Alignment with national and international submission standards
