Your key to a successful regulatory journey. A good understanding of the regulatory strategy and plan that is required is critical to enable successful and timely commercialization of a medicinal product. Celegence provides tailored strategic and procedural support to enable pharmaceutical companies to successfully realize their goals and become launch-ready.

Ensuring successful and timely commercialization.

Clarity on the regulatory frameworks in the countries of interest, leads to a clear regulatory strategy and pathway.

Celegence supports both emerging and established pharmaceutical companies in defining and executing strategic regulatory activities, including:

  • Considerations for the establishment of a local company and/or support in the process of qualifying as micro-, small- and medium-sized enterprises (as applicable)

  • Support in preparation and submission of clinical trial applications (e.g. US INDs, EU CTAs)

  • Identifying a strategy for filing (e.g. expedited or reliance pathways, EU national, mutual- recognition, or centralized procedure, timeline planning

  • Preparation and submission of paediatric investigation plans (PIPs)

  • Preparation, submission and maintenance of Orphan Drug Designation (ODD) applications (including transfers, as applicable)

  • Preparing for Scientific Advice meetings and necessary briefing packages

  • Preparing for Pre-submission meetings

  • Preparing and filing for Marketing Authorization Applications (MAAs) and follow up submissions (including document writing)

  • Strategic planning for post-approval development and product maintenance

  • Support in relevant system set-up (e.g. SPOR, IRIS, XEVMPD, CTIS, PML, EMA service desk, EMA account management)

Additional Information

Download the latest brochure of our capabilities and services.

Pharmaceutical Industry Regulatory Affairs - Celegence

A scientific and pragmatic approach 

By asking the question ‘What’s the benefit for the patient?’ and defining the regulatory solution that aligns with the core of your product and data, Celegence guides you to the right strategy. Using sound arguments supported by science, vision and robust data, to support the Health Authorities in safeguarding patients and increase access to new innovative medicines.

Hands-on procedural support and informed decision making

Managing regulatory procedures requires specific skill sets and time. We have the expertise, experience and capabilities to support you in ensuring the right Marketing Authorisation is applied for and the right procedure is followed, in each individual case. Celegence can inform you of which options would qualify and what the potential pros and cons would be.

Life-cycle management of Module 3 documentation

Chemistry, Manufacturing and Controls (CMC) related content from registration dossiers is often subject to many changes. That means that relevant documents and data are to be well maintained in the post-authorization phase.

We can help you select the correct variation/supplement types, supportive documents and conditions and the correct wording that is used to qualify for the variation classification. This includes writing of the covering letter, populating the application form and other documents required to support the change. Finally, our Publishing and Submission team can take care of the end-to-end publishing and submission of your regulatory dossiers.

And if it is of interest, we can go one step further, by also assisting you in the maintenance of your regulatory information management systems.

SME (Small and Medium-sized Enterprise) representation

Celegence has obtained the EMA SME status, meaning we are eligible to benefit from provisions for financial and administrative assistance for SMEs, as laid down in Regulation (EC) No 2049/2005.

What is SME status and what does it mean for our customers?

To promote innovation and development of new medicines, EMA supports micro-, small- and medium-sized enterprises (SMEs) by providing incentives during pre-marketing as well as post-authorization procedures.

Celegence can support non-European Economic Area (EEA) based enterprises by accessing these incentives granted by EMA through the Celegence SME status. This means that you, as an SME customer, can access several benefits e.g., EMA fee deferrals/waivers for scientific advice, inspection procedures, pharmacovigilance and administrative services.

As such, we can also support the creation and maintenance for stand-alone Module 3.S and Module 3. Drug Master Files and Active Substance Master files.

Contact Us

How to Get Started with Celegence Regulatory Affairs Consultancy and Support

To get started with regulatory affairs consultancy and support, please contact us today. We would be happy to discuss your specific needs and provide you with a quote.

  • This field is for validation purposes and should be left unchanged.