Submissions

Submissions
  1. Clinical Trial Applications (CTA)RLM Consulting has a considerable experience in the writing of Investigational Medicinal Product Dossiers (IMPD) and Investigator Brochure (IB) as part of the packages to be submitted to the national Agencies for Clinical Trial Applications (CTA). RLM Consulting take 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 our customers to prepare efficient and appropriate responses to agency questions and objections. We help at the review process, provide input on the interpretation of questions, relate with the Authorities to get clarification, help to understand the documentation required.
      • RLM Consulting assists their customer for interpreting consolidated lists of questions and objections, in the light of the assessment reports that are provided by the rapporteur and co-rapporteur.
  3. For manufacturers of active ingredients: writing and submission Active Substance Master Files (ASMF) and dossiers for certification of suitability of the monographs of the European Pharmacopoeia (CEP)
  4. For biotechnology derived products:
      • Preparation of Viral Safety Dossiers
      • Writing of Biosafety dossiers for CTA and MAA involving GMO’s.