Editing and proofreading

We can offer an independent and unbiased review of the manuscripts you have prepared, to help you bring it to top quality standards. This will include:

• Checking for scientific accuracy and consistency

• Controlling and adjusting selling, grammar and writing style

• Assessment of convincing strength of argumentation

• Formatting

We can deliver the subsequent regulatory documentation in all therapeutic indications, in strict compliance with regulatory requirements and guidelines:

• Chemistry, manufacturing and controls (CMC) section

• Preclinical study protocols, reports summaries and overviews

• Investigator’s Brochures (IB) and data summaries

• Clinical study protocols, reports, summaries and overviews

• Case Report Forms (CRFs), Patient Information and Informed Consents

• Clinical Trial Applications (CTA) and Ethic Committee (EC) submissions

• Development plans

• Briefing Packages for regulatory authorities

• Expert reports and statements

• Common technical Document (CTD) modules or Investigational Medicinal Product Dossier (IMPD)

• Replies to regulatory authorities

Medical, scientific, technical and didactic writing

We can assist you for the preparation of the following documents in all scientific and medical fields:

• Manuscripts for publication in the national and international, peer-reviewed journals

• Scientific brochures

• Data summaries

• Review articles

• Briefing packages

• Expert reports Congress abstracts and posters, slide presentations

• Reports and minutes from scientific meetings and international symposia

• Information brochures for doctors, pharmacists, medical representatives and patients

• Manuscripts for the specialist and lay press

• Advertising Support

• Scientific part of Due Diligence dossiers

• Books and book chapters

• Literature searches and reviews