Services

Specialist support tailored to your organisation

Operational and leadership expertise for pharmaceutical teams across the Benelux and European Union.

Marketing authorisation applications, lifecycle management, regulatory intelligence, strategy, gap analyses and agency interaction.

QMS maintenance, distribution, administrative release, complaints, SOPs, change control, audits and inspections.

Adverse event follow-up, local PV activities, training and support with product safety matters.

Scientific and pharmaceutical enquiries, medical information and review of promotional materials.

Leadership and project support

Interim leadership of a Regulatory Affairs department, including organisation, staffing, task allocation and budget management.

Representing your department internally and your company in trade associations and external regulatory meetings.

Focused support for portfolio acquisitions, marketing authorisation transfers and RIMS implementations.

Tell us where your team needs support. We will contact you personally.