Companies

🏢 Top Drug Regulatory Affairs Companies in Ahmedabad

Drug Regulatory Affairs Companies in Ahmedabad: Ahmedabad, a prominent city in Gujarat, India, has emerged as 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: Drug Regulatory Affairs Companies in Mumbai – Comprehensive Guide 2025

These organizations 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 Ahmedabad

1. Zydus Lifesciences Ltd.

Location: Ahmedabad
Services: Regulatory submissions, CTD dossier preparation, pharmacovigilance
Highlight: Zydus Lifesciences, formerly known as Cadila Healthcare, is a leading pharmaceutical company with a strong presence in the regulatory affairs domain, offering services across various therapeutic areas.

2. Cadila Pharmaceuticals Ltd.

Location: Ahmedabad
Services: Regulatory strategy, compliance consulting, global submissions
Highlight: Cadila Pharmaceuticals is one of the largest privately held pharmaceutical companies in India, providing comprehensive regulatory affairs services for a wide range of products.

3. Intas Pharmaceuticals Ltd.

Location: Ahmedabad
Services: Regulatory submissions, eCTD dossier preparation, lifecycle management
Highlight: Intas Pharmaceuticals is a multinational pharmaceutical company with a robust regulatory affairs team, supporting global markets including the US, EU, and emerging countries.

4. Troikaa Pharmaceuticals Ltd.

Location: Ahmedabad
Services: Regulatory documentation, global submissions, compliance audits
Highlight: Troikaa Pharmaceuticals specializes in novel drug delivery systems and has a dedicated regulatory affairs department ensuring compliance with international standards.

5. Concord Biotech Ltd.

Location: Ahmedabad
Services: Regulatory submissions for biopharmaceuticals, compliance consulting
Highlight: Concord Biotech is a biotechnology company focusing on fermentation-based APIs, with regulatory approvals from major global agencies.

6. Lincoln Pharmaceuticals Ltd.

Location: Ahmedabad
Services: Regulatory affairs for international markets, dossier preparation
Highlight: Lincoln Pharmaceuticals offers a wide range of pharmaceutical products and has a strong regulatory affairs team managing global submissions.

7. Amneal Pharmaceuticals Pvt. Ltd.

Location: Ahmedabad
Services: Regulatory submissions, compliance management, lifecycle support
Highlight: Amneal Pharmaceuticals is a global generic and specialty pharmaceutical company with a significant presence in regulatory affairs operations in Ahmedabad.

8. Senores Pharmaceuticals Pvt. Ltd.

Location: Ahmedabad
Services: Regulatory affairs for ROW markets, CTD dossier compilation
Highlight: Senores Pharmaceuticals specializes in regulatory submissions for Rest of the World (ROW) markets, ensuring compliance with diverse regulatory requirements.

9. Vivanza Biosciences Ltd.

Location: Ahmedabad
Services: Regulatory documentation, compliance consulting, global submissions
Highlight: Vivanza Biosciences offers comprehensive regulatory affairs services, catering to various international markets with a focus on quality and compliance.

10. Pharmazone India Pvt. Ltd.

Location: Ahmedabad
Services: Regulatory submissions, eCTD dossier preparation, regulatory consulting
Highlight: Pharmazone provides end-to-end regulatory affairs services, including dossier preparation and submissions for various regulatory authorities.

11. Tashi Pharma Pvt. Ltd.

Location: Ahmedabad
Services: Product registrations, regulatory submissions, compliance support
Highlight: Tashi Pharma offers comprehensive support from product registrations to final regulatory approvals, ensuring timely and efficient submissions.

12. Regcure Pharma

Location: Ahmedabad
Services: Regulatory consulting, compliance management, dossier preparation
Highlight: Regcure Pharma is a trusted regulatory affairs consultancy firm specializing in the pharmaceutical industry, offering tailored solutions for regulatory compliance.

Read More: Top Drug Regulatory Affairs Companies in Hyderabad


📋 Services Offered by These Companies

Drug Regulatory Affairs Companies in Ahmedabad 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 Ahmedabad

Drug Regulatory Affairs Companies in Ahmedabad 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 Ahmedabad

Ahmedabad’s robust pharmaceutical industry and the presence of numerous Drug Regulatory Affairs Companies in Ahmedabad 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, Ahmedabad offers a wealth of resources and expertise in drug regulatory affairs.

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