Pharma Regulatory Affairs Consulting Services in India
Artixio provides end-to-end pharmaceuticals regulatory affairs support in India, including strategic consulting, international product registration, regulatory process management, and post-marketing compliance services.
Services We Offer
With over three decades of specialized experience, Artixio has helped more than 50 global pharmaceutical companies enter the Indian market. Through practical pharma regulatory affairs strategies in India and a focus on results, we guide companies through complex processes and support them in reaching their commercial goals.
Artixio provides complete pharmaceuticals regulatory affairs consulting services in India. We support pharma companies from early development to post-approval maintenance. Our Highly experienced consultant team helps with strategic advice, regulatory writing, dossier preparation, labeling, promotional material review, and regulatory information management. With the right mix of experience and regulatory insight, we make it easier for your pharmaceutical product to stay regulatory compliant and move forward confidently in the Indian market.
Pharmaceutical Regulatory Affairs Solutions in India (CDSCO)
Classification of Pharmaceuticals in India
CDSCO regulates drug registration in India under the Drugs and Cosmetics Act. Manufacturers and importers must apply through Form 44 and pay the applicable fees. The pharma regulatory affairs approval process in India includes dossier preparation, technical review, and coordination with authorities to move the application forward.
Types of licences under CDSCO
Cost for drug license in India
| License Type | Cost |
|---|---|
| Retail | INR 45,000 |
| Wholesale | INR 40,000 |
| Manufacturing | INR 1,00,000 |
Pharma Regulatory Affairs Process In India
Preparation phase
- The pharmaceutical product intended for registration must be clearly identified, with a comprehensive understanding of its therapeutic value and regulatory requirements.
- The required documents, formulation and manufacturing details, stability data should be ready for submission.
Application submission to CDSCO
- The dossier should be submitted to CDSCO in the CTD (common technical document) format for a NDA or ANDA application
- Application have to be submitted via online portal and fees have to be paid along with submission of required documents.
Evaluation by the CDSCO
- The application will go through the screening process to make sure its completeness.
- The application will be thoroughly reviewed for its safety, efficacy and quality data.
- The CDSCO will also conduct GMP inspections.
Approval of the application
- Upon thorough evaluation and satisfaction of the Central Drugs Standard Control Organisation (CDSCO), approval is granted for the drug's market entry.
Regulatory Process for Pharmaceuticals in India
Timeline
Labelling requirements
- Drug product name
- Net content (in weight/volume/number of units)
- Active ingredients
- Name and address of the manufacturer
- Batch number
- Any special precaution or remark
Post Marketing Surveillance
- Adverse drug reactions reporting
- Pharmacovigilance programme of India
- Signal detection and analysis
- Periodic safety Update reports (PSUR’s)
- Risk evaluation and mitigation strategies
- Medical & Technical Writing
- Due Diligence and Gap Analysis
- Dossier Preparation and compilation
- Dossier Publishing & Submission
- Product Registration
- Marketing Authorization Holder (MAH/LR)
- Investigation New Drug Application (IND) / Clinical Trial Application (CTA)
- New Drug Application (NDA) / Marketing Authorization Applications (MAA)
- Post Approval Lifecycle Maintenance
- Artwork and Label Review
- Ad Promo Review
- Distributor and Import Assistance
Collaborate with Artixio’s India Expertise with Seamless Global Delivery
- Successful Approvals and Product Lifecycle Maintenance for 300+ products
- Diverse Products Experience across Complex Products Categories and Therapeutic Areas
- Strong Regional Expert with 30+ years of experience
- Proven Experience in End-to-End Product Value Chain from Concept to Commercialization
- Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
- ISO 9001:2015 quality standards governed services
- Customer focused, flexible services and solutions
- Flexible Business Model including project based, managed services and FTE staffing model
- Hybrid-Local-Centralized Support across Regulatory functions
FAQs
1. What is the validity of drug registration?
2. In India, what are the requirements for clinical trial?
3. What are the requirement for importing drugs to India?
4. When is the re-registration or renewal is done?
5. What are some of the main responsibilities of CDSCO?
Still Have Questions ?
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Medical & Technical Writing
Publishing & Submission
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