Regulatory Affaires


Clinical trial submissions

Preparation and Submission of Application Dossiers

acromion provides regulatory compliant high quality application dossiers for submission to the competent authorities and ethics committees.

Our team is dedicated to ensure the completeness and accuracy of your submission documents and of the required supportive information of your investigational medicinal product.

  • Preparation of overviews and summaries, patient information leaflets and application formats
  • Complete submission writing, organisation, assembly, and filing to the Competent Authorities and the Ethics Committees
  • Follow-up activities such as preparation of responses to regulatory agencies, e.g. answering deficiency letters

Expert review of scientific documents

Medical Writing

Whether you require documents as modular part of the submission package or an integrated clinical research package, our medical writers provide their expertise and commitment to the full range of materials at all phases of development.

Medical Writing

Address

acromion GmbH

Europaallee 27-29
50226 Frechen

Phone: +49 (0)2234-20 37 37-0
Fax: +49 (0)2234-20 37 37-9


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