Regulatory Affairs: Developing strategies

Application procedure management

For clients wishing to apply for a new marketing authorisation, we develop custom tailored regulatory strategies.


Based on our longtime experience with many European regulatory agencies, we provide guidance during the procedure or even manage the entire procedure on behalf of the applicant. We can also act as the applicant, marketing authorisation holder and pharmaceutical entrepreneur.


We are familiar with all types of applications and procedures. 


Types of procedures:

  • Centralised Procedures
  • Decentralised Procedures (DCP)
  • Mutual Recognition Procedures (MRP)
  • National Procedures in European countries


Types of applications: 

  • Full applications
  • Generic applications
  • Informed consent applications
  • Traditional Use Registrations
  • Well Established Use applications and others.



Our regulatory services cover all stages of the procedure

Strategic planning and preparation

  • Business Development strategy
  • Regulatory strategy
  • Regulatory, clinical and technical due diligence
  • Streamlined continuous process for compiling eCTD dossiers

Pre-submission dossier assessment & quality assurance

        In depth review of all aspects of the dossier in order to avoid deficiencies, including a 
    • thorough assessment of the Clinical and Non-Clinical documentation
    • thorough assessment of the manufacturing process and the corresponding documentation (Module 3, Quality)

Support during the procedure & management of deficiencies

  • Detailed support in resolving any deficiencies identified by regulatory agencies, including issues related to production and quality control.
  • Continued project management.

Finalisation during the national phase & translations

    • Managing the final national phase of the procedure with each regulatory agency. 
    • Preparing high quality translations of the SPC & PIL thanks to our network of native speakers with a university degree in life sciences.

Overview of services related to different modules of the dossier

 Modules 1 & 2 Pharmacovigilance
  • Services of a Qualified Person for Pharmacovigilance
  • Pharmacovigilance System
  • Risk Management Plans
Medical writing
  • Expert reports, including Module 2.4 Non-Clinical Overview, Module 2.5 Clinical Overview
  • Patient Information Leaflet (PIL)
  • Summary of Product Characteristics (SPC)
Administrative documents
 Module 3

Technical writing
Technical advice during product development

  • support by our in-house pharmacists specialised in Technology & Biopharmaceutics
  • cooperation with external specialists and contract manufacturers, if required
 Modules 4 & 5

Literature reviews & assessment of clinical trials
Advice on clinical trial design

Cooperation with Clinical Research Organisations