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Regulatory Deliverables

Creating a Foundation for Regulatory Success

It is imperative to carefully prepare for pre-authorization regulatory milestones and deliverables to prevent missteps from derailing product development and registration.

Whether this is your first or fifth product to market, it’s critical to understand the current thinking and expectations of European Union (EU) regulatory agencies – whether this is the European Medicines Agency (EMA) committees (CHMP, COMP, PRAC, or PDCO) or national authorities. Additionally, regulatory deliverables must address specific concerns and questions unique to your particular drug, biologic, or medical device and business objectives. With a highly polished regulatory plan and deliverables that is based on the best science, you can improve the likelihood of successfully obtaining product approval, thus avoiding unnecessary delays to market.

Trusted Global Regulatory Partners

With more than 35 years of experience, our team is comprised of science-focused experts who have a deep understanding of regulatory requirements and a positive working relationship with EMA committees, as well as with the national agencies. We partner with you to fully plan and prepare key deliverables for each submission and provide guidance on:

  • Competitive landscape and overall development strategy, including risks and mitigations
  • Prevailing regulatory agency guidance and expectations
  • Potential for expedited submission and approval
  • Developing an exclusivity strategy, including regulatory, orphan, and pediatric considerations
  • Overall timelines, key junctures for regulatory engagement, decision points, and outcomes
  • Preparing fully compliant dossiers and submission documentation

Orphan Drug Designation (ODD)

We have experience with complex orphan situations, such as highly competitive markets or target indications that span multiple orphan designations, for which Sponsors need a greater depth of expertise to ensure a successful outcome.

Our expertise encompasses the detailed planning and strategic assessment of the data package which will be required to maintain an orphan designation upon submission of the marketing authorization application (MAA). In many cases, this is a greater undertaking than obtaining the original designation and can have a critical impact on product exclusivity, pricing, and reimbursement.

Our experts understand the challenges of correctly positioning your product against similar products that are already approved or currently in development. We have an unmatched understanding of the needs and expectations of the EMA’s Committee for Orphan Medicinal Products (COMP) and can guide you through the challenges of successfully demonstrating your product’s unique value.

Pediatric Investigational Plan (PIP)

While Sponsors may submit pediatric development plans to both the Food and Drug Administration (FDA) and the EMA, the EMA’s Pediatric Committee (PDCO) requires a PIP with a greater depth of information and level of commitment.

A successful PIP is a pre-requisite to MAA submission. Potential missteps in pediatric strategy and the content of the agreed PIP can negatively impact your regulatory strategy and MAA submission timeline.

Our regulatory experts understand the nuances of what PDCO expects and can provide strategic guidance to help you avoid potential pitfalls in your PIP submission.

Accelerated Approvals Pathway

Launched in 2016, PRIME (PRIority MEdicines) is a scheme to enhance support for the development of medicines that target an unmet medical need. PRIME is similar in scope and intent to the FDA’s Breakthrough Therapy Designation.

In addition, Sponsors benefiting from PRIME can also expect to be eligible to take advantage of EMA’s accelerated assessment when their MAA is submitted.

Our experts can help determine your product’s eligibility for accelerated approval and develop the appropriate documentation to support an accelerated or PRIME application. We serve as a liaison with the rapporteur from the EMA’s Committee for Medicinal Products for Human Use (CHMP) or from the Committee on Advanced Therapies (CAT) and can help prepare scientific advice requests at key development milestones.

Scientific Advice Briefing Book

The scientific advice briefing book sets the stage for receiving valuable advice from the CHMP/EMA or national competent authorities. Writing an effective briefing book begins with a thorough understanding of the science and a well-defined regulatory strategy. Effective advice requests can improve MAA approval rates while unfavorable advice can create significant challenges in the application process.

Our experts understand the finer details of a successful regulatory strategy and the right way to approach scientific advice requests to ensure successful outcomes.

Clinical Trial Applications

Our team has expertise in the strategy and submission of Clinical Trial Applications (CTAs) for a broad range of product types. We also have a vast amount of experience in the evolving national requirements in the field of cell and gene therapy. Specific CTA-related services include:

  • Competent authority submissions
  • Document authoring and coordination
  • GMO applications
  • CTA project management
  • Ethics submissions

We manage the CTAs for a diverse range of clients, from biotech companies running a single trial, to bigger pharmaceutical companies with a large number of new applications per year and a large volume of substantial amendments.

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Need Help Navigating the Dynamic Regulatory Market to Bring Your Product Concept to Market?

Contact us to discover how 30+ years of regulatory experience using a strategic and scientific approach can deliver successful and expeditious outcomes.

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