Navigate regulatory requirements with confidence

Guiding regulatory success

Streamline the regulatory pathway, minimize risks and accelerate time to market with a regulatory roadmap that aligns with your product development goals. A regulatory strategy applies indication-specific regulatory guidance and extensive research to create an optimal approach for your regulatory submissions.

With our Regulatory Consulting services, you can focus on what you do best — innovating and developing life-changing solutions.

Tailored support for regulatory authority interactions

Confidently engage with regulators fully equipped to meet potential challenges head on. IQVIA’s regulatory strategy experts support you in all aspects of your interactions with regulatory authorities worldwide. Strategic guidance prepares you for the complex regulatory landscape, ensuring effective communication and compliance with global standards. Our team assists in preparing for agency meetings, submissions and applications, focusing on minimizing risk and accelerating development timelines.

Investigational New Drug and Investigational Medicinal Product Dossier consulting services

Ensure your IND or IMPD submission meets the stringent requirements of regulatory agencies worldwide. Overcome regulatory affairs complexities with experts well-versed in the specific requirements for these applications. We will assist you in compiling the necessary data and documentation, meeting rigorous global standards.

Accelerated approval pathways — fast-tracking your success

Understanding the complexities of accelerated pathways is nuanced and difficult. Strategic guidance on navigating accelerated approval pathways across various regulatory jurisdictions worldwide ensures your product meets the eligibility criteria. We can assist in preparing and submitting applications for these programs, so your product stands the best chance of receiving expedited review and approval.

Our team of experts is well versed in the specific requirements and procedures for expedited programs, such as the FDA’s Fast Track, Breakthrough Therapy and Accelerated Approval programs in the U.S., the EMA’s PRIME and Conditional Marketing Authorization in Europe, and the UK’s Innovative Licensing and Access Pathway.

Expediting approval with special designations

In the competitive pharma/biotech industry, obtaining special regulatory designations can provide a significant advantage. Our regulatory strategy consulting services are designed to guide you through this process.

Our team possesses in-depth knowledge of the specific prerequisites and processes for these designations. We aid in the preparation and submission of applications, ensuring your product fulfills the eligibility criteria and optimizes its chances of securing applicable designations. We have a proven track record of supporting:

Guiding your pediatric strategy

Pediatric Investigation Plan (PIP) and Pediatric Study Plan (PSP) are a critical component of the regulatory process both in the US and the Europe. By leveraging our PIP/PSP consulting services, you can confidently and effectively overcome the complexities of pediatric drug development, expediting your product’s journey to market.

PIPs and PSPs have unique requirements. Maximize the chance of obtaining approval with a partner experienced in pediatric regulations. We offer assistance in the preparation and submission of these plans, or waivers when appropriate, ensuring your product meets the necessary criteria.

Product registration — your gateway to market access

Product registration is a pivotal step in the journey from the lab to the global market. Simplify the process, overcome potential obstacles and expedite your product’s entry to the market with registration expertise that spans global regulatory jurisdictions.

We assist in all stages of the product registration process, from deciphering the specific requirements of each jurisdiction, preparing the necessary documentation, formatting and publishing your submission and liaising with regulatory authorities until registration is achieved.