Top Drug Regulatory Affairs Companies in Hyderabad
Drug Regulatory Affairs Companies in Hyderabad: Hyderabad, often called the Pharma Capital of India, is home to some of the largest pharmaceutical companies and CROs in the country.
With a dense concentration of research-driven pharmaceutical and biotech firms, Hyderabad has become a leading destination for drug regulatory affairs services.
Also Read: Drug Regulatory Affairs Companies in Bangalore
This blog will cover the top drug regulatory affairs companies in Hyderabad, their key services, and why the city plays a pivotal role in India’s global pharmaceutical compliance network.
🌟 Why Hyderabad for Drug Regulatory Affairs?
- Headquarters of major Indian pharma giants like Dr. Reddy’s, Aurobindo Pharma, and Natco Pharma.
- Hub for Clinical Research Organizations (CROs) and Regulatory Outsourcing Firms.
- Proximity to institutions like NIPER Hyderabad and IICT boosting regulatory talent pool.
- Preferred location for USFDA/EMA submission support teams.
🏢 Top Drug Regulatory Affairs Companies in Hyderabad
1. Dr. Reddy’s Laboratories
Location: Bachupally, Hyderabad
Services: Global regulatory submissions, dossier development, lifecycle management
Highlight: Strong regulatory presence in US, EU, and ROW markets.
2. Aurobindo Pharma Ltd
Location: HITEC City & Bachupally
Services: ANDA/DMF submissions, CTD dossiers, compliance audits
Why it stands out: In-house regulatory support across generics, biosimilars, and oncology.
3. GVK Bio (Aragen Life Sciences)
Location: Nacharam, Hyderabad
Services: Regulatory writing, IND/NDA/MAA support, regulatory strategy consulting
Note: Partner to major global pharma companies for submission-ready documents.
4. Sai Life Sciences
Location: Genome Valley
Services: Regulatory chemistry support, CMC documentation, submission strategy
Specialization: Strong in API and CDMO regulatory submissions.
5. Freyr Solutions (Hyderabad Office)
Location: Gachibowli
Services: eCTD submissions, RIMS, labelling, global regulatory consulting
Note: Global regulatory consulting firm with services in 120+ countries.
6. Vimta Labs Ltd
Location: Cherlapally, Hyderabad
Services: Clinical research, regulatory documentation, product registrations
Key Strength: CRO with integrated regulatory and lab support.
7. Syneos Health
Location: Madhapur
Services: Regulatory strategy, dossier publishing, health authority liaison
Why include: Major global CRO with regulatory operations in India.
đź“‹ Services Offered by These Companies
- CTD/eCTD dossier preparation & publishing
- Regulatory strategy for USFDA, EMA, CDSCO
- IND/NDA/ANDA/DMF filings
- Labelling and artwork compliance
- Regulatory Information Management Systems (RIMS)
- Clinical trial regulatory document support
- Lifecycle management and variations
đź’Ľ Career Opportunities in Hyderabad (RA Domain)
Hyderabad has job roles such as:
- Regulatory Affairs Executive / Manager
- Global Regulatory Submissions Associate
- Regulatory Medical Writer
- Labeling and Artwork Reviewer
- eCTD Publishing Specialist
Job Portals:
👉 LinkedIn | Naukri | PharmaTutor
🎓 For Freshers: How to Enter Regulatory Affairs in Hyderabad
- Complete a PG Diploma or Certificate in Drug Regulatory Affairs
- Learn basic tools like Extedo, Lorenz docuBridge for eCTD publishing
- Apply for internships at CROs or regulatory consulting firms
- Follow CDSCO/USFDA guidelines regularly to stay updated
👉 Read: Top Free & Paid Regulatory Affairs Certifications (internal link suggestion)
🔍 Emerging Trends in Regulatory Affairs in Hyderabad
As Hyderabad continues to attract global pharmaceutical investments, the landscape of regulatory affairs is also evolving rapidly.
Drug Regulatory Affairs Companies in Hyderabad are now integrating digital regulatory solutions such as eCTD publishing software, AI-driven document management, and cloud-based RIMS platforms to streamline compliance and accelerate approval timelines.
Additionally, Hyderabad’s firms are increasingly focusing on biosimilars, vaccines, and novel drug delivery systems, prompting specialized regulatory frameworks and talent.
The presence of a tech-savvy workforce and growing partnerships between IT and pharma companies further strengthen Hyderabad’s position as a hub for innovation-driven regulatory excellence.
🗺️ Bonus Tip: Visit Genome Valley
Genome Valley, near Shamirpet, is Hyderabad’s biotech & pharma innovation cluster.
It hosts many CROs and RA teams—ideal for job seekers and pharma professionals to network and explore opportunities.
đź“Ś Conclusion-Drug Regulatory Affairs Companies in Hyderabad
Hyderabad has solidified its reputation as a top-tier city for regulatory affairs in India, thanks to its rich pharma ecosystem, talent availability, and strategic infrastructure.
Whether you’re looking for a job, outsourcing partner, or collaboration—Hyderabad offers everything you need in the regulatory space.