🏢 Top Drug Regulatory Affairs Companies in Pune: List You must Know
Drug Regulatory Affairs Companies in Pune: Pune, a prominent city in Maharashtra, 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: 🏢 Top Drug Regulatory Affairs Companies in Ahmedabad
These organizations provide a range of services including regulatory submissions, dossier management, pharmacovigilance, and compliance consulting, catering to both domestic and international markets.
List of Drug Regulatory Affairs Companies in Pune
🏢 Leading Drug Regulatory Affairs Companies in Pune
1. Emcure Pharmaceuticals Ltd.
Location: Hinjawadi, Pune
Services: Regulatory submissions, CTD dossier preparation, pharmacovigilance
Highlight: Emcure Pharmaceuticals is a leading pharmaceutical company with a strong presence in the regulatory affairs domain, offering services across various therapeutic areas.
2. Lifepoint Research
Location: Wakad, Pune
Services: Regulatory support for clinical trials, development of new chemical entities (NCEs)
Highlight: Lifepoint Research offers expert assistance in drug development programs, including regulatory support for clinical trials and the development of NCEs.
3. Global Institute of Regulatory Affairs (GIRA)
Location: Chinchwad, Pune
Services: Regulatory affairs training, eCTD training, pharmacovigilance courses
Highlight: GIRA provides comprehensive training programs in regulatory affairs, including full-time, part-time, and distance learning courses, catering to the needs of professionals and job seekers.
4. TechnoBridge
Location: Pune
Services: Regulatory affairs training, job placement assistance
Highlight: TechnoBridge offers regulatory affairs courses with 100% placement assistance, covering essentials as per standard guidelines and providing practical exposure to regulatory processes.
5. CliniWings
Location: Pune
Services: Regulatory affairs training, clinical data management
Highlight: CliniWings offers top-quality regulatory affairs training programs designed to provide a thorough understanding of the regulatory environment in the pharmaceutical and healthcare industries.
6. Sohan Healthcare Pvt. Ltd.
Location: Hadapsar, Pune
Services: Regulatory affairs services, compliance consulting
Highlight: Sohan Healthcare is a fully integrated pharmaceutical company offering regulatory affairs services, including compliance consulting and support for regulatory submissions.
7. Statistical Pharma
Location: Pune
Services: Regulatory affairs, pharmacovigilance
Highlight: Statistical Pharma provides regulatory affairs services, including support for audits and inspections, monitoring regulatory guidelines, and ensuring compliance.
8. Humano Forte
Location: Pune
Services: Regulatory affairs, international business development
Highlight: Humano Forte offers regulatory affairs services, including coordination with regulatory teams, compliance management, and support for international business development.
9. Kelly Services
Location: Pune
Services: Regulatory affairs staffing and consulting
Highlight: Kelly Services provides staffing solutions and consulting services in regulatory affairs, catering to the needs of pharmaceutical and healthcare companies.
10. Varex Imaging
Location: Pune
Services: Regulatory affairs data management
Highlight: Varex Imaging specializes in regulatory affairs data management, utilizing regulatory information management (RIM) tools to ensure accuracy and compliance.
📋 Services Offered by These Companies
Drug Regulatory Affairs Companies in Pune 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 Pune
Drug Regulatory Affairs Companies in Pune 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 Pune
Pune’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, Pune offers a wealth of resources and expertise in drug regulatory affairs.