A Trusted Biologics End-to-End Regulatory Service Provider in India
A complete end-to-end support right from product conceptualization to post marketing experience
Artixio is a regulatory services company in India providing clients a complete support through their pharmaceutical commercialization journey. We have wide experience in providing efficient strategies for product registration to maximize commercial potential by reducing time to market. Our team has decades of experience in successfully launching and commercializing life-sciences products.
India’s Biological Market
The Regulatory authority of India, Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India regulates the registration of biological product in India. Sugam Portal is the interface to access the online services by CDSCO and to register the biologic product in India. India’s Biological sector includes vaccines, blood products, rDNA, stem cells and cell based products.
Approval Process for a biologic product in India
Approval Process of a biologic product in India involves following steps:
Artixio provides following services for the biological products in India
- Product strategy, cost analysis and risk assessment
- Intellectual Property landscape
- Regulatory intelligence and Health Authority insights
- Advisory, Scientific writing and regional support
- Project Management
- Document Management and Publishing
- Compliance driven labeling content
- Data driven decisions right from product development, product launch to post marketing support
- Product branding
Why Artixio
Experts with decades of experience in successful approval of products
Team with experience to address key questions for market access
Scalable product services supporting the entire product lifecycle
Regional expertise
5000+ Licenses approved and maintained
Helps innovations reach their users in complaint and timely manner
Preferred Regulatory consultant for product registration in India
FAQs
What are the categories for approval of a biological product in India?
A biological product in India can be approved in following categories:
- Drug approved in another country/Salt of an Approved drug
- Investigational New Drug
- Approved New Drug
- New Dosage form
- New indication
- New route of administration
What are the different forms available for biological product permission to market, its import and to conduct clinical trials in India?
Form 44/45/46 NOC are available for permission to market/import and to conduct clinical trials in India respectively.
What are the fees required to be paid for a biological product approval in India?
| Sr. No. | Purpose | Fees Paid |
|---|---|---|
| 1 | Marketing Authorization (Form 44) | Rs 50,000 and Rs 15,000 for regularization of permission |
| 2 | Application for License to import drugs for examination, test or analysis (Form 12) | Rs 100 for each product and Rs 50 for each subsequent product |
| 3 | Subsequent approval of Marketing Authorization (Form 44) | Rs 15,000 |
| 4 | Clinical Trial Phase I (Form 44) | Rs 50,000 |
| 5 | Clinical Trial Phase II (Form 44) | Rs 25,000 |
| 6 | Clinical Trial Phase III (Form 44) | Rs 25,000 |
| 7 | Registration of site (Form 40) | 1,500 USD for each site |
| 8 | Registration of product | 1,000 USD for each product |
| 9 | Import License (Form 8) | Rs 1,000 for each product and Rs 100 for each subsequent product |
How is your regulatory strategy supporting the product evaluation for successful commercialization?
Our regulatory strategy covers evaluation of several aspects for successful commercialization of the product including:
- Therapeutic area, Intellectual property, and competitor’s landscape
- Clinical development roadmap
- Regional Regulatory intelligence and Insights based on the health authority interactions
- Product strategy
- Product cost analysis
- Risk assessment
Regulatory Expertise Across
Multiple Countries
India
Vietnam
Mexico
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines
Biologics Product and Market Strategy
Artixio can support new cosmetic products by conducting a through assessment of market
landscape to generate insights that can help differentiate and place the product better and
make it stand out in global markets. The product differentiation is created right from
innovation at technology and ingredients level, claims, packaging, pricing and marketing level.
At Artixio, our team of techno-commercial experts in cosmetics can assist throughout the
product journey.
Our insights driven Product Roadmap covers,
Competitive
Landscape
Formulation
Assessment
Competitor Claims /
Label Benchmarking
Approved Claims
Product Key
Differentiators
Assess pricing and produc
placement strategy agains
similar products
Assess distribution / sales
channels, promotions and
digital strategy
Product Branding and Launch Strategy
- Product and Brand Identify
- Branding Guidelines
- Brand Design and Communication Strategy
- Packaging and Artwork Graphic Design
- Marketing Collateral Design and Development
- Merchandize Design
- Digital Content and Design
Communication and Digital
- Biologics Product Label Review
- Biologics Ingredients and Product Compliance Review
- Artwork and Promotional Material Revien
- Product Information File Review (PIF)
- Notification
- Registration with Health Authority
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