Pharmaceutical applications & tools

We prepare and submit your eCTD, VET eSubmissions and NeeS applications. For eCTD publishing we use the eCTD Manager tools of Extedo. We convert your CTD (often paper based) dossier into eCTD (PDF) whereafter publishing follows in eCTD or NeeS format.

We offer specialised pharmaceutical training programs in RA, RIP, Pharmacovigilance, GDP and GMP, aligned with EU and BENELUX regulations. Our tailor-made trainings are available in English, Dutch, French and German.

Consultation with target groups for readability testing of Patient Information Leaflets (PIL), also referred to as Readability User Testing (RUT). We have guided over 250 package leaflets to EU submission with a 100% approval rate.

Internal and external GxP audits, including supplier audits, government inspections, CAPA plans and yearly Management Reviews, to keep your quality system compliant and continuously improving.

A new business model in which we unburden our clients when e-submitting new medicinal products for registration by in-house managing of all pharmaceutical services upfront registration, and transferring ownership rights upon completion. A gamechanger for clients who focus on marketing and sales of Generic and OTC medicines and Health Products.

Are you a MAH of one or more 'dormant' registrations that you want to dispose of? We audit and validate the complete file, document a deficiency list with a CAPA plan, and assess the feasibility of transferring the MA to another interested MAH.