Your Key to a Successful Strategy & Execution

A good definition and execution of the regulatory strategy is critical to enable successful and timely commercialization of a medicinal product.

Celegence provides both strategic and procedural support to enable pharmaceutical companies successfully realize their goals.

Ensure Successful & Timely Commercialization

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

  • Considerations for the establishment of a company
  • Identifying a strategy for filing (e.g. expedited or reliance pathways, EU national, mutual- recognition, or centralized procedure)
  • Filings for Orphan Drug Designation (ODD) applications
  • 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

  • Strategic planning for post-approval development and product maintenance

A scientific and pragmatic approach

By raising the question ‘What’s in there for the patient’ and by going back to the core of your product and data, Celegence guides you to the right strategy. This leads to a pragmatic (so not dogmatic) interpretation of regulatory guidance and understanding of the original intention of the requirements. Using sound arguments supported by science, vision and reliable data, Health Authorities will become your best friend in safeguarding patients.

(Hands-on) procedural support and informed decision making

Managing regulatory procedures requires specific skill sets and time. Regulatory professionals from the applicant and/or Marketing Authorization Holder (MAH) can run these procedures. However, sometimes the applicant/MAH lack that specific knowledge and/or time. For example, what procedure should be selected in the EU (NP, DCP, MRP, RUP, CP)? What Marketing Authorization type do we apply for (e.g. Full, Generic, Hybrid, Established use, Biosimilar, Informed consent)? Celegence can inform you what of the options would qualify and what the pros and cons will be.

From the Netherlands we can easily communicate with all national competent authorities worldwide and with EMA. Celegence is familiar with the various procedure types in the EU (National, Decentralised, Mutual Recognition and Centralised). Also the EMA and various associated committees (e.g. PDCO, PRAC, CHMP, CAT, SAWP and QRD) can be approached through us. So, if you do not have the time or would like to have our help, we can be your contact person on behalf of your company.

We help you in preparing cover letters, application forms and other details for appropriate, correct and consistent information. We help you with the selection of variation types, supportive documents and conditions and the correct wording that is used to qualify for the variation classification. In addition, our Documents- and Dossier team can take care of the end-to-end publishing and publishing and submission of your regulatory dossiers.

SME (Small and Medium-sized Enterprise) representation

Celegence 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 reduction for scientific advice, inspection procedures, pharmacovigilance and administrative services.

Local Regulatory Affairs

We strive for faster, better and smarter regulatory affairs which means really understanding client’s requirements, improved communications and delivering the best quality services.

Extending/establishing your local regulatory affairs team

Regulatory affairs responsibilities at the local level include a wide range of activities. Among other things, the work requires team members to have good project management skills, strong linguistic, analytical, and communication skills, a great eye for detail, and a sense of urgency. All of that, on top of in-depth knowledge of local regulatory procedures. A skill-set that is scarce and needs to be built within teams.

Celegence can take on any kind of local regulatory affairs activity, that involves:

  • EU centralized products, mutual recognition products, decentralized products and national products

  • English, Dutch and Portuguese speaking countries (other options can be discussed)

Activities that Celegence leads and supports include:

  • Local product information creation and maintenance (e.g. alignment of the product information with the company core data sheet, performing/coordinating and translations, artworks coordination)
  • Communication with national competent authorities (e.g. addressing linguistic comments, preparing for scientific advice, agreeing on local
  • Review of (non-)promotional material according to applicable guidelines

  • Providing regulatory affairs expertise to brand teams (e.g. collecting strategic input from local teams on early drafts of new/revised product information)
  • Driving local regulatory policy activities (e.g. representation in the local industry association)
  • Liaising with the relevant teams at Headquarter and/or other affiliates
  • Ensuring regulatory authority approval of compassionate use and/or other early access programs for (not yet) approved products
  • Local dossier preparation and submission
  • Supporting one-off projects (e.g. following CHMP Article 5(3) opinions)

A pragmatic approach in which we strive for automation and simplicity

Celegence team members are pragmatic and look for procedural simplicity where possible. Meaning they do not ‘just’ do whatever you ask them to do.

In addition, they can assess potential areas for improvement or suggest approaches for automation or simplification of routine tasks. If wished, a senior regulatory affairs consultant could support this assessment, defining recommendations and eventually support/coordinate the implementation thereof.

Additional Information

Download the latest brochure of our capabilities and services.

Pharmaceutical Industry Regulatory Affairs - Celegence

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