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.

Qdossier 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 Portugese speaking countries (other options can be discussed)

All-round local regulatory support available

Activities that Qdossier 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 Risk Minimization Material or Dear Healthcare Professional Letters and accompanying distribution plans)
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

Qdossier 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 make an assessment of potential areas for improvement or suggest approaches for automation or simplification of routine tasks. If wished, a senior regulatory affairs consultant could support in this assessment, defining recommendations and eventually support/coordinate the implementation thereof.

More information

Marloes van der Geer
+31 416 707 998
contact

Qdossier writers have the skill set to provide the information in an unambiguous way; meaning that factual information will often be provided in tabular formats and bulleted lists, rather than narratives.