10 Best Drug Regulatory Affairs Companies in Vadodara – Complete Guide
Drug Regulatory Affairs Companies in Vadodara: Vadodara, often referred to as the cultural capital of Gujarat, is also a significant hub for the pharmaceutical industry in India.
As the pharmaceutical landscape in India evolves, Drug Regulatory Affairs Companies in Vadodara are playing a crucial role in ensuring global compliance and streamlined product approvals.”
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 Goa – 2025 Guide
Drug Regulatory Affairs Companies in Bangalore
🏢 Leading Drug Regulatory Affairs Companies in Vadodara
These organizations provide a range of services including regulatory submissions, dossier management, pharmacovigilance, and compliance consulting, catering to both domestic and international markets.
1. Alembic Pharmaceuticals Ltd.
Location: Vadodara, Gujarat
Services: Regulatory affairs, R&D, API development
Highlights: Established in 1907, Alembic Pharmaceuticals is one of India’s oldest pharmaceutical companies. The company has its headquarters in Vadodara and is involved in the manufacture of pharmaceutical products, pharmaceutical substances, and intermediates. Alembic has a significant presence in the regulatory affairs domain, supporting global submissions and compliance.
2. Sun Pharmaceutical Industries Ltd.
Location: Halol, Vadodara, Gujarat
Services: Regulatory affairs, manufacturing, compliance
Highlights: Sun Pharma’s Halol facility is a state-of-the-art plant manufacturing various dosage forms, adhering to USFDA standards. The company has a dedicated regulatory affairs team managing global submissions.
3. Zydus Lifesciences Ltd.
Location: Vadodara, Gujarat
Services: Regulatory affairs, manufacturing, compliance
Highlights: Zydus Lifesciences, formerly known as Cadila Healthcare, has a significant presence in Vadodara. The company is involved in the development and manufacture of a wide range of pharmaceuticals, with a strong focus on regulatory compliance and global submissions.
4. Century Pharmaceuticals Ltd.
Location: Vadodara, Gujarat
Services: API manufacturing, regulatory affairs
Highlights: Founded in 1982, Century Pharmaceuticals is involved in the manufacture of Active Pharmaceutical Ingredients (APIs). The company offers various services, including long-term contracts for manufacturing intermediates and development of new APIs, with a focus on regulatory compliance.
5. Comed Chemicals Ltd.
Location: Vadodara, Gujarat
Services: Regulatory affairs, manufacturing
Highlights: Comed Chemicals specializes in the manufacture of pharmaceutical products and has a dedicated regulatory affairs team. The company is involved in regulatory submissions, including applications, notifications, and responses to regulatory inquiries, ensuring compliance with various international regulatory standards.
6. ACT Agrochem Pvt. Ltd.
Location: Vadodara, Gujarat
Services: Regulatory affairs, agrochemical manufacturing
Highlights: ACT Agrochem is engaged in the manufacture of agrochemicals and has a regulatory affairs team responsible for regulatory submissions, including applications, notifications, and responses to regulatory inquiries, ensuring compliance with various international regulatory standards.
7. Regen Biocorps
Location: Vadodara, Gujarat
Services: Regulatory affairs, biotechnology
Highlights: Regen Biocorps specializes in biotechnology and has a regulatory affairs team responsible for regulatory submissions, including applications, notifications, and responses to regulatory inquiries, ensuring compliance with various international regulatory standards.
8. Indu Regulatory Services (IRS)
Location: Vadodara, Gujarat
Services: Pharmaceutical regulatory consulting
Highlights: Indu Regulatory Services is an emerging consulting company based in Vadodara, offering regulatory affairs services to the pharmaceutical industry.
9. Medicon Lifesciences
Location: Vadodara, Gujarat
Services: Regulatory affairs consulting for USA, EU, and emerging markets
Highlights: Medicon Lifesciences specializes in regulatory affairs consulting, providing expertise in submissions and approvals for the USA, EU, and emerging markets.
10. Krosyl Pharmaceuticals
Location: Vadodara, Gujarat
Services: Regulatory affairs, documentation management
Highlights: Krosyl Pharmaceuticals handles regulatory affairs tasks, including managing incoming and outgoing materials with proper records and documentation.
📋 Services Offered by Drug Regulatory Affairs Companies in Vadodara
Most Drug Regulatory Affairs Companies in Vadodara offer services like CTD dossier submission, lifecycle management, and regulatory strategy development.
The companies 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 Vadodara
Vadodara 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 Vadodara
Vadodara’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 or a global pharma exporter, choosing from the right Drug Regulatory Affairs Companies in Vadodara can streamline your compliance journey
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 Vadodara offers a wealth of resources and expertise in drug regulatory affairs.