Medical & Regulatory

The medical & regulatory affairs department covers consultancy and interim management services in the pharmaceutical industry, OTC and in healthcare related markets.

We tailor our services to meet your needs.

Consultancy & interim management in regulatory affairs

To cover assignments such as:

  • MAA and MAA variations, labeling, information and advertising, QA/QC, pharmacovigilance, drug safety, PSUR's, SOP's, Clinical trial applications.

Consultancy and interim management in medical affairs

To cover assignments such as:

  • Medical information: Promotional material review and approval, scientific product support, Q&A's, standard response letters
  • Medical writing: Protocol writing, study reports, manuscripts, patient informed consent, CRF development