Best Drug Regulatory Affairs Companies in Kolkata – Complete Guide
Drug Regulatory Affairs Companies in Kolkata: Kolkata, the capital of West Bengal, has a rich history in the pharmaceutical industry, dating back to the establishment of India’s first pharmaceutical company.
Today, the city hosts numerous pharmaceutical companies and consultancies specializing in Drug Regulatory Affairs (DRA).
Over the years, several Drug Regulatory Affairs Companies in Kolkata have gained national and international recognition for their regulatory expertise.
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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 Kolkata
This article highlights top-rated Drug Regulatory Affairs Companies in Kolkata offering CTD dossier support and global compliance services.
1. Bengal Chemicals & Pharmaceuticals Ltd. (BCPL)
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory compliance
Highlights: Established in 1901 by Acharya Prafulla Chandra Ray, BCPL is India’s first pharmaceutical company. It manufactures a range of pharmaceutical products and has a dedicated regulatory affairs team ensuring compliance with national and international standards.
2. Emcee Pharmaceuticals
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory affairs
Highlights: Founded in 1980, Emcee Pharmaceuticals specializes in the production of liquid formulations, capsules, and tablets.
The company has a regulatory affairs department responsible for ensuring compliance with various regulatory authorities.
3. Stadmed Pvt. Ltd.
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory compliance
Highlights: Stadmed is known for its range of pharmaceutical products, including Alkasol, Pulmocod, Aminozyme, and Entrozyme.
The company has a regulatory affairs team that ensures adherence to regulatory requirements.
4. Aurio Pharma Laboratories
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory affairs
Highlights: Established in 1972, Aurio Pharma produces over 200 varieties of pharmaceutical products.
The company has a regulatory affairs department that manages compliance with national and international regulations.
5. Burnet Pharmaceuticals
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory compliance
Highlights: Founded in 1982, Burnet Pharmaceuticals offers a wide range of pharmaceutical products.
The company has a regulatory affairs team that ensures compliance with various regulatory standards.
6. Pfizer India
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory affairs
Highlights: Pfizer, a global pharmaceutical company, has operations in Kolkata.
The company has a dedicated regulatory affairs team managing global submissions and compliance.
7. Sanofi India
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory compliance
Highlights: Sanofi, a multinational pharmaceutical company, operates in Kolkata with a focus on quality assurance and regulatory compliance, supporting global pharmaceutical markets.
8. Cipla Ltd.
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory affairs
Highlights: Cipla, a leading Indian pharmaceutical company, has a presence in Kolkata.
The company has a regulatory affairs team responsible for ensuring compliance with various regulatory authorities.
9. Dr. Reddy’s Laboratories
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory compliance
Highlights: Dr. Reddy’s Laboratories operates in Kolkata with a focus on manufacturing and regulatory compliance, supporting a wide range of pharmaceutical products.
10. Zydus Lifesciences Ltd.
Location: Kolkata, West Bengal
Services: Pharmaceutical manufacturing, regulatory affairs
Highlights: Zydus Lifesciences, formerly known as Cadila Healthcare, has a presence in Kolkata.
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.
📋 Services Offered by Drug Regulatory Affairs Companies in Kolkata
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 Kolkata
Kolkata 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 Kolkata
Kolkata’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 seeking expert consultation or a career opportunity, Drug Regulatory Affairs Companies in Kolkata can be your trusted regulatory partners.
Whether you’re a job seeker, a pharmaceutical company looking for regulatory support, or a professional aiming to collaborate with experts, Kolkata offers a wealth of resources and expertise in drug regulatory affairs.