REGISTRATION & MARKETING AUTHORIZATION

Smoothly navigate regulatory paths

As the consumer health market evolves, so do the regulations ensuring quality, safety and efficacy. IQVIA Consumer Health's experts help you navigate complex OTC, food supplement and personal care regulatory environments and develop seamless pathways to registration.

IQVIA Consumer Health helps optimise opportunities with country- or region-specific evidence-based regulatory and market authorization approaches for bringing products to market 

  • Regulatory Content Work We have the in-house capabilities to ensure your path to regulatory success is flawless thanks to our regulatory content management systems, trial master file services, dossier development capabilities and more 
  • Access New Markets We help you to expand your reach by using our extensive knowledge and expertise of the global and local markets through our geographic expansion solutions, regulatory pathway strategies and regulatory intelligence
  • Clinical Trials IQVIA Consumer Health’s heritage in clinical trials is well known and we bring that same expertise to consumer healthcare as well, from real world evidence, trial design. Find out more

Regulatory & Market Authorization

Regulatory Meeting Planning and conduct

Delivering the right information, at the right time with the right message is key to driving your regulatory relationships. IQVIA Consumer Health’s  experts work closely with you to prepare training tools, provide appropriate attendance information in a timely fashion, attend and assist with presentations, and other services necessary to achieve a successful meeting.

Driving geographic expansion

Situation

An international consumer health company acquired a complex brand portfolio and retained IQVIA Consumer Health to find out if the portfolio could be rolled out to new markets (>15 countries) in and outside the EU and provide strategies to overcome potential hurdles

Solution

The regulatory documentation of the portfolio was assessed and issues identified (e.g, non-permitted ingredients, claim issues.) Proposed strategies to enable market access with minor changes to product or claim. Risk analysis was provided on the potential consequences of launching products whose ingredients or claims were non-compliant.

Result

The client endorsed our regulatory recommendations and is now in further implementation phase

EU regulatory strategy for a natural product range

Situation

A mid-sized consumer health company wanted to launch different natural food supplements, cosmetics, herbal drugs and OTC drugs products in the EU market and required IQVIA Consumer Health to identify and validate the best regulatory pathways and strategies.

Solution

For all different natural product classes, hurdles and opportunities were identified and regulatory strategies proposed to overcome issues. EU and nation-specific import rules and regulatory specifics for natural products were provided including details on EU Novel Food regulations and requirements for food supplements, herbal drugs, medical devices and cosmetics.

Result

The client endorsed our regulatory recommendations and is now in further implementation phase

Import & regulatory strategies for CBD-based product

Situation

A mid-sized consumer health company wanted to explore a launch of a highly purified CBD (cannabidiol) product in the EU market as a food supplement and required IQVIA Consumer Health to explore and validate identify export/import rules and regulatory strategies.

Solution

Uncovered and provided validated export/import pathways, mapped regulatory possibilities down to an individual EU state level and proposed strategies to manage current gaps in the available documentation material.

Result

The client endorsed our regulatory recommendations and is now in further implementation phase

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