Product Registration Services for
Global Lifesciences Markets

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

Why Pharma Wizard 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.

Tech-Assisted Regulatory Intelligence Driven Services Platform

Our proprietary platform shortlisted for CPHI Pharma Awards 2024, is a tech-assisted, AI enabled, regulatory intelligence driven platform that supports products registration strategies and activities in global markets.

Commitment to Excellence

With proven experience from successful approvals and key learnings from different markets across product and therapeutic categories, Pharma Wizard is committed to excellence by implementing best management and regulatory practices geared towards efficient, reliable solutions for our customers’ regulatory needs.

Connecting Innovation with Global Markets

At Pharma Wizard, we help life sciences companies bring their innovations to global markets faster and more efficiently. With a strong understanding of regional regulations and market dynamics, we make the regulatory process smoother—so patients and end users get access to the products they need, wherever they are.

Pharma Wizard, 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
Centralized Multi-Country / Multi-Product Strategy for Efficiency
Cost-effective, flexible pricing tailored to your needs

FAQS

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 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 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. Pharma wizard, through its local offices and its affiliate network can support MAH services.

Still Have Questions ?

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Specialized Regulatory Affairs Services Across Multiple Industries

Pharmaceuticals

MedTech

Cosmetics

Nutrition

Biologics

Veterinary

Expert Regulatory Services To Streamline Compliance

Product Registration (FDA, EMA, GCC, ASEAN)

Navigating the complex regulatory pathways of top-tier health authorities requires precision and expertise. We provide end-to-end support for obtaining market authorization from global bodies, including the US FDA, European EMA, GCC countries, and ASEAN region. Whether you need dossier compilation (eCTD/ACTD), gap analysis, or query management, our team ensures your product meets the stringent compliance standards required for a successful launch in these high-value markets.