Drug Regulatory Affairs Companies in Mumbai – Comprehensive Guide 2025
Drug Regulatory Affairs Companies in Mumbai: Mumbai, the financial capital of India, is also a significant hub for the pharmaceutical industry.
The city hosts numerous pharmaceutical companies, Contract Research Organizations (CROs), and consulting firms specializing in Drug Regulatory Affairs (DRA).
Also Read: Top Drug Regulatory Affairs Companies in Hyderabad
Drug Regulatory Affairs Companies in Mumbai provide a range of services including regulatory submissions, dossier management, pharmacovigilance, and compliance consulting, catering to both domestic and international markets.
🏢 Leading Drug Regulatory Affairs Companies in Mumbai
1. Sun Pharmaceutical Industries Ltd
Location: Goregaon, Mumbai
Services: Regulatory submissions for generics, biosimilars, and specialty drugs
Highlight: Sun Pharma has dedicated regulatory teams for the USFDA, EMA, TGA, and CDSCO markets.
2. Cipla Ltd
Location: Vikhroli, Mumbai
Services: CTD dossier compilation, labeling compliance, global regulatory submissions
Highlight: Cipla has a robust regulatory infrastructure serving over 100 countries with a strong focus on respiratory and HIV drugs.
3. Glenmark Pharmaceuticals
Location: Andheri (E), Mumbai
Services: IND/NDA filing, regulatory strategy, global dossier support
Highlight: A key player in branded generics with global regulatory partnerships and presence in over 80 countries.
4. Wockhardt Ltd
Location: Bandra-Kurla Complex (BKC), Mumbai
Services: eCTD publishing, pharmacovigilance, regulatory lifecycle management
Highlight: Known for high-quality documentation and a strong USFDA submissions track record.
5. Alkem Laboratories Ltd
Location: Lower Parel, Mumbai
Services: Regulatory affairs for generics, OTC drugs, and specialty pharmaceuticals
Highlight: Alkem has a significant presence in both domestic and international markets, with a focus on compliance and quality.
6. Teva Pharmaceuticals
Location: Navi Mumbai
Services: Regulatory affairs for generic and specialty applications for the US, Europe, and other global markets
Highlight: Teva has a large and skilled Regulatory Affairs team based in Mumbai.
7. Rubicon Research Pvt. Ltd
Location: Thane, Mumbai
Services: Contract research, formulation development, dossier development in ANDA/CTD format
Highlight: Rubicon Research is an IP-led, specialty pharmaceutical company with a strong focus on regulatory services.
8. Nuvo Consultancy
Location: Mumbai
Services: Regulatory strategy building, eCTD & SPL, DMF management, dossier management, lifecycle management
Highlight: NUVO Consultancy offers efficient and reliable regulatory and quality support, focused on international requirements.
9. Adveesan Consulting
Location: Mumbai
Services: Global regulatory strategies, documentation, submissions, and lifecycle management of drugs, vaccines, and devices
Highlight: Adveesan Consulting has expertise in global regulatory strategies and offers a broad range of services including scientific advice and medical writing.
10. Zyirn
Location: Mumbai
Services: Regulatory affairs consulting for pharmaceutical, biotech, agrochemical, and medical devices companies
Highlight: Zyirn provides guidance and support for the design and implementation of regulatory strategies.
11. Lambda Therapeutic Research Ltd
Location: Mumbai
Services: Regulatory affairs services including handling applications for new drugs and catering to diverse regulatory requirements
Highlight: Lambda’s expertise extends to handling a wide array of applications for new drugs, catering to diverse regulatory requirements.
12. Meredoc Pharma Consultancy
Location: Mumbai
Services: Regulatory services including CDSCO registration, state FDA registration, medical writing, and EMA CTD module summaries
Highlight: Meredoc offers high-quality regulatory and allied services to pharmaceutical companies and clinical research organizations.
13. JD Pharma Consultants
Location: Mumbai
Services: Regulatory compliance, plant setup, quality assurance, documentation, audits, and overall project management
Highlight: JD Pharma Consultants provides expert guidance and support to pharmaceutical manufacturers in various areas.
14. ProductLife Group
Location: Mumbai
Services: Regulatory and compliance services, pharmacovigilance, and strategic consulting
Highlight: PLG offers outsourcing services in the areas of regulatory affairs, compliance, and pharmacovigilance.
📋 Services Offered by These Companies
Drug Regulatory Affairs Companies in Mumbai listed above offer a wide range of services in the field of regulatory affairs, including:
- CTD/eCTD Dossier Preparation: Compiling and submitting dossiers in the Common Technical Document format for regulatory approvals.
- Regulatory Strategy Development: Crafting strategies for regulatory submissions and approvals in various markets.
- Pharmacovigilance: Monitoring and reporting adverse drug reactions to ensure drug safety.
- Labeling and Compliance: Ensuring that product labeling meets regulatory requirements.
- Lifecycle Management: Managing the entire lifecycle of a product from development to post-marketing.
- Medical Writing: Preparing clinical trial reports, regulatory documents, and scientific publications.
- Regulatory Consulting: Providing expert advice on regulatory requirements and compliance.
💼 Career Opportunities in Regulatory Affairs in Mumbai
Mumbai offers numerous career opportunities in the field of regulatory affairs. Positions commonly available include:
- Regulatory Affairs Executive/Manager
- Regulatory Compliance Specialist
- Pharmacovigilance Officer
- Medical Writer
- Regulatory Consultant
Job seekers can explore opportunities on platforms like Naukri, LinkedIn, and Indeed.
🎯 Conclusion-Drug Regulatory Affairs Companies in Mumbai
Mumbai’s robust pharmaceutical industry and the presence of numerous regulatory affairs companies make it a prime location for professionals seeking opportunities in this field.
Whether you’re a job seeker, a pharmaceutical company looking for regulatory support, or a professional aiming to collaborate with experts, Drug Regulatory Affairs Companies in Mumbai offers a wealth of resources and expertise in drug regulatory affairs.