Submissions

  1. Clinical Trial Applications (CTA) RLM Consulting has a considerable experience in the writing of Investigational Medicinal Product Dossiers (IMPD) and Investigator Brochures (IB) as part of the packages to be submitted to the national Agencies for Clinical Trial Applications (CTA). RLM Consulting takes care of the preparation, submission and follow-up of CTA in ALL EU.
  2. Marketing Authorisation Applications (MAA)
    RLM Consulting has a long experience in the preparation of marketing authorisation applications (MAA) and in helping to prepare efficient and appropriate responses to agency questions and objections.
  3. Orphan Drug Designations: Writing, submission, negotiation with the EMA and FDA.
  4. Preparation of Viral Safety dossiers.
  5. Writing of Biosafety dossiers for CTA and MAA involving genetically modified organisms (GMO).