Artixio

Biological Regulatory Consulting Services In India

Expert biologics regulatory consultant in India offering end-to-end services for approvals, documentation, and lifecycle management support.

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:

Biologicals Regulatory Services India | CDSCO Approval

Biologicals Regulatory Services India | CDSCO Approval

Why Artixio For Biological Regulatory Services In India?

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
Form 44/45/46 NOC are available for permission to market/import and to conduct clinical trials in India respectively.
Sr. No.PurposeFees Paid
1Marketing Authorization (Form 44)Rs 50,000 and Rs 15,000 for regularization of permission
2Application for License to import drugs for examination, test or analysis (Form 12)Rs 100 for each product and Rs 50 for each subsequent product
3Subsequent approval of Marketing Authorization (Form 44)Rs 15,000
4Clinical Trial Phase I (Form 44)Rs 50,000
5Clinical Trial Phase II (Form 44)Rs 25,000
6Clinical Trial Phase III (Form 44)Rs 25,000
7Registration of site (Form 40)1,500 USD for each site
8Registration of product1,000 USD for each product
9Import License (Form 8)Rs 1,000 for each product and Rs 100 for each subsequent product
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

Still Have Questions ?

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Regulatory Expertise Across Multiple Countries

India
Vietnam
Mexico​
Vietnam
United States
Brazil
Europe
Malaysia
Taiwan
China
Thailand
Philippines

Industries we serve

Pharmaceuticals

Cosmetics

Nutrition

Medtech

Biologics

Veterinary

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

Communication and Digital

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