Product Registration Services for Global Lifesciences Markets

Expand and Accelerate your global product launch strategy leveraging Artixio’s integrated, tech-assisted Global Product Registration Platform.

Services We Offer

Why Artixio For Your Registration Solutions?

We continue to help Globally Leading Lifesciences Companies with complex, diverse and sizeable portfolio of products with their global product launch through intelligence and insights driven, tech-assisted product registration services leveraging our teams’ decades of product / TA experience, regional experience managing HA expectations to meeting compliance requirements for successful product license approvals. Our services encompass full spectrum of product classification assessment to dossier preparation to obtaining licenses across product categories such as pharmaceuticals, biologics, devices, diagnostics, combination drugs, cosmetics, nutraceuticals and veterinary.

Strategy -> Submission -> Approval

Artixio, Your Go-To-Partner for Global
Product Registration

Successful Approvals and Product Lifecycle Maintenance for 5000+ products
Intelligence, Insights & Experience Driven
HA & Professional Network to Navigate Gray Areas
Tech Assisted Approach
Standardized, Checklist Based
Efficient Project Management
Milestone Based Approach
Centralized Multi-Country / Multi-Product Strategy for Efficiency

FAQs

What are the key considerations for Product Registration in Global Markets?

In order to register new products (pharmaceuticals, devices, biologics, cosmetics, nutraceuticals, animal health etc), manufacturer need to take certain aspects in to consideration such as, applicable product classification, product registration regulatory pathway based on reference country, documentation requirements, local clinical studies / testing requirements, registration timelines and cost, local representation requirement, translation requirements, document notorization / legalization requirements, forms to be filled, GMP requirements, import license requirements, labelling and advertisement regulations among others.

What are the challenges faced during Product Registration in Global Markets?

International manufacturers face multiple challenges during product registration including, lack of knowledge of regional regulations, reliable legal representative with proven experience, subject matter expertise with Therapeutic Area / Product Category specific experience, transparency of information, Health authority experience, regional cultural and language nuances, on ground administrative support, accurate product classification, insights from health authorities related to unclear / ambiguous regulations, warehousing, distribution process clarity, import related challenges among others.

What are the requirements for Local Marketing Authorization Holder?

In most countries, foreign companies are required to appoint an authorized local representative that could be an individual or a company. In order to act as a Marketing Authorization Holder, the local company is required to hold certain licenses related to pharma business. Artixio, through its local offices and its affiliate network can support MAH services.

What are the additional local studies required for global Product Registration?

Depending on the product’s approval status in the country, reference country in scope, therapeutic area, complexity of the molecule, countries may require additional data. The data may include clinical studies data from local population, bioequivalence testing studies from local labs, medical devices testing and others. Artixio has a network of hospitals, clinical trial organizations, testing labs to support your local testing requirements, if applicable.

How will Artixio helps us with Product Registration in international markets?

Artixio has a centralized Regulatory Projects team with experience in managing multi-country registration for multiple products from diverse categories. The Projects team, together with our regional regulatory experts will work with you to understand your product, its current approval status against the requirements in countries of interest. They will help you through the registration process right from classification, gap analysis, HA meetings, dossier preparation and submission till approval.