🏢 Drug Regulatory Affairs Companies in Roorkee – Complete Industry Overview
Drug Regulatory Affairs Companies in Roorkee: Rorkee, a city in Uttarakhand, is traditionally known for IIT Roorkee, but it’s also becoming a significant pharmaceutical and regulatory hub.
With the presence of several Drug Regulatory Affairs Companies in Roorkee, pharmaceutical businesses here benefit from expert support for both domestic and international compliance.
Also Read: 🏢 Drug Regulatory Affairs Companies in Visakhapatnam – Comprehensive Guide
The presence of WHO-GMP and USFDA-approved units, cost-effective manufacturing, and skilled labor has led to the rise of regulatory service providers.
Companies here handle national and international regulatory filings, dossier preparations, and pharma consulting.
🏗️ Why Roorkee Is Becoming a Regulatory Affairs Destination
- Affordable infrastructure and access to skilled pharmacy graduates
- Proximity to major pharma cities like Haridwar and Dehradun
- High presence of third-party manufacturers and export-oriented units (EOUs)
- Multiple companies working with formulation & compliance teams under one roof
🏢 Top Drug Regulatory Affairs Companies in Roorkee
This list of top Drug Regulatory Affairs Companies in Roorkee helps you identify the most reliable partners for CTD submissions, labeling, and strategic documentation.
1. Jubilant Generics Limited
- Services: Regulatory dossier creation, global compliance filing, GxP documentation
- Highlights: Their facility in Roorkee is USFDA and WHO-approved, and their RA team manages dossiers for major global markets.
2. Lucent Biotech Limited
- Services: Dossier documentation, pharmacovigilance setup, label compliance
- Highlights: Known for timely global submissions and GLP/GMP adherence.
3. Ravian Life Science Pvt. Ltd.
- Services: ACTD/CTD/eCTD submission, RA strategy, licensing
- Highlights: Strong expertise in strategic planning for product approvals globally.
4. Vadsp Pharmaceuticals
- Services: Third-party formulation, regulatory backup, document QA
- Highlights: A trusted partner for PCD pharma players and international RA consultants.
🌍 Regulatory Reach of Roorkee-Based Companies
Roorkee firms frequently submit to:
- CDSCO (India)
- USFDA
- EMA (Europe)
- PMDA (Japan)
- TGA (Australia)
- WHO PQ
This indicates maturity in documentation systems and regulatory foresight.
🧩 Services Offered by Drug Regulatory Affairs Companies in Roorkee
- CTD / eCTD / ACTD compilation and submission
- DMF and dossier creation (Modules 1–5)
- Regulatory audit assistance
- Pharma labeling and packaging compliance
- Lifecycle updates and variation filing
- Stability studies and justification reports
- QMS documentation and SOP alignment
🎓 Training & Talent Pool in Roorkee
Roorkee is home to several colleges offering B.Pharm and M.Pharm courses.
IIT Roorkee also contributes indirectly through its biosciences and interdisciplinary labs. Many professionals here pursue:
- PG Diplomas in Regulatory Affairs
- ICH-GCP, PV, and CTD workshops
- Internships with local pharma firms
📊 How to Select the Right RA Partner in Roorkee
✔ Check submission history (e.g., how many ANDA/CTD submissions done)
✔ Ask about in-house RA specialists vs. freelance support
✔ Evaluate SOP-driven culture and training records
✔ Consider certifications: ISO 9001, WHO-GMP, USFDA approvals
✔ Confirm if eCTD software & validation tools are used
💼 Job Scope in Drug Regulatory Affairs (Roorkee)
Common job profiles:
- Regulatory Affairs Officer / Executive
- PV Analyst
- Dossier Filing Specialist
- Regulatory Documentation Coordinator
- QA & Compliance Lead
- Medical Writing Assistant
Popular portals: Naukri, LinkedIn, PharmaTutor, and direct company career pages.
🔚 Conclusion
In recent years, Roorkee has also seen growth in regulatory tech adoption.
Many local companies are now using eCTD software, digital QMS tools, and cloud-based documentation systems to streamline submissions and audits — making them more competitive for global regulatory partnerships.
Roorkee is no longer just an educational town – it’s now a competitive pharma destination. For companies looking to outsource or build regulatory capabilities, Roorkee offers:
- Affordable regulatory partners
- High submission success rate
- Growing talent base
- Fast adoption of eCTD & digital tools
Working with any of these reputed Drug Regulatory Affairs Companies in Roorkee can accelerate your product’s path to regulatory approval while ensuring ongoing compliance.
Whether you’re launching a new molecule or expanding to regulated markets, Drug Regulatory Affairs Companies in Roorkee can be a smart strategic move.