We provide strategic and hands-on support for EU and BENELUX regulatory affairs, tailored to the client’s needs and organisation. Our consultants not only have a strong scientific background and a solid regulatory technical knowledge, but also excellent project management and communication skills. We genuinely enjoy helping you to perform better.
We can either assist the company’s regulatory affairs department, or operate as independent drivers of specialised regulatory activities, or even function as a fully-staffed regulatory affairs department.
We provide strategic and hands-on support
for EU and BENELUX regulatory affairs
Our expert team can:
- advise on regulatory strategies, submit your applications, run your procedures, liaise with health authorities
- act as head of Regulatory Affairs for start-up companies or provide a ‘virtual’ regulatory department for small/medium-sized companies
- complement existing resources at headquarters of BENELUX affiliates
- offer interim staffing solutions during sickness, maternity leaves, holidays, or while awaiting a permanent hire
- provide additional resource to meet a project deadline or to cope with workload peaks
- accommodate flexible or part-time work schemes of regulatory staff to ensure continuity for your projects and teams
- professionally handle specific outsourced regulatory projects
- train newly hired junior staff
- coach and assist with specialised subject matters (e.g., first time to handle a scientific advice, prepare for an agency meeting, write a PIP, apply for orphan drug status, request a re-examination, coordinate a Referral, etc.)
- offer regulatory ‘helpdesk’ contracts for companies who wish to consult us on a regular basis for imminent regulatory questions. Expert advice is just one phone call away.