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EMA Services: Pre-Authorization

Regulatory Strategy/Gap Analysis

Whether you’re working on a national, European, or global level, we can help you develop an appropriate regulatory strategy from early development through product maintenance or anywhere in between. Specifically, some of the services we offer include:

  • Gap analysis of existing or new dossiers
  • Draft and coordinate the Regulatory Product Development Plan, covering all aspects of development
  • Advise on regulatory deliverables and timelines
  • Advise on interactions with Healthy Authority (HA)
  • Advise on filing strategy (i.e., legal basis for the application, choice of procedure, etc.)

Regulatory Deliverables

Pre-authorization regulatory deliverables are a critical part of the regulatory approval process. We can help you develop and submit the best possible deliverables for submission to the EMA, working with you to successfully move your product through the development lifecycle.

These deliverables include:

  • Orphan drug designation
  • Pediatric Investigational Plan (PIP)
  • PRIME eligibility request
  • Scientific advice briefing book

Medical/Technical Writing

Preparing to submit an application to the EMA can be overwhelming and stressful. We are here to help make the entire process as smooth and efficient as possible. As such, we can assist with your Investigational Medicinal Product Dossier (IMPD) and Marketing Authorization Application (MAA) submissions by reviewing and/or authoring the following:

  • IMPD and Investigator’s Brochure (IB) submissions
  • Preclinical and clinical study protocols
  • Module 2, including Quality Overall Summary, Nonclinical Overview and Summary, and Clinical Overview and Summary
  • Module 3 Quality, including drug substance and product sections
  • Modules 4 and 5
  • Risk Management Plans (RMP)
  • Environmental Risk Assessment (ERA) for GMOs

Scientific Advice & Pre-Submission Meetings

As you prepare your submission, a Sponsor can seek scientific in one of two ways: (1) at a national level from their individual member states regulatory authorities, or (2) from the EMA’s CHMP. The requirements for obtaining scientific advice varies based on the type you are seeking and may or may not require a face-to-face meeting to discuss the advice being provided. Navigating the rules and regulations for each type of advice can be challenging, but we have the knowledge and experience to help you obtain the best information that will ultimately help you obtain marketing authorization (MA).

Although scientific advice is not a requirement for approval, it is important to note that MAA approval rates are much higher for companies who seek the agency’s advice and follow it.

Our specific scientific advice services include:

  • Lead development of briefing book package
  • Prepare briefing documents and submission of briefing book package
  • Prepare and submit responses to questions
  • Conduct rehearsals prior to attending HA meetings
  • Lead HA meetings

EMA Submissions

Preparing and submitting your application to the EMA is the final step to receiving marketing authorization (MA) for your product. Making sure it is done the right way the first time around will save you a significant amount of resources and will help get your product on the market faster. We can help you do exactly that. In order to make this process as smooth as possible, we offer the following assistance:

  • Manage dossier compilation for HA submissions
  • Prepare Module 1, regional administrative documents
  • Prepare submission in accordance with eCTD
  • Prepare and submit responses to questions
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