📄 About Us
Who We Are
At DrugRegulatoryAffairs.in, we are dedicated to demystifying the complexities of pharmaceutical regulatory processes in India and beyond. Our mission is to become a leading digital hub for accurate, timely, and practical guidance on drug approvals, compliance, and regulatory strategies.
Our team consists of regulatory professionals, pharmacists, and subject matter experts with hands-on experience in filing with CDSCO, managing CTD dossiers, complying with global standards (USFDA, EMA), and supporting clinical trials documentation.
Our Mission
To empower pharmaceutical professionals, companies, and students with accessible, reliable, and actionable knowledge in drug regulatory affairs.
Our Vision
To bridge the gap between regulations and industry by providing a central, user-friendly platform for guidance, learning, and collaboration in drug regulatory science.
What We Offer
- Step-by-step regulatory guides and updates
- Insights into Indian and international regulatory frameworks
- Downloadable templates and SOPs
- Expert articles and compliance tips
- Information on upcoming workshops and training programs
Certifications & Affiliations
We work in alignment with and reference the following institutions and authorities:
- Central Drugs Standard Control Organization (CDSCO)
- Ministry of Health and Family Welfare (MoHFW)
- International Council for Harmonisation (ICH)
- WHO Guidelines
- USFDA & EMA directives (for comparative analysis)