Documentum Medical Writing Consultancy  

Documentum provides professional regulatory and scientific medical writing and project management services to the pharmaceutical and biotechnology industries. We partner with your team to facilitate and expedite your medical writing projects.

 

We specialise in medical writing solutions for biotech and we offer

 

  • Planning, coordination, writing and editing of high quality regulatory documents including clinical study reports, investigators brochure and various summary reports

 

  • Timely and professional planning and delivery of pre-clinical and clinical study results in manuscripts for publication in peer-reviewed medical journals

 

  • Accurate and persuasive reporting of clinical data in abstracts, posters and other presentations for medical conferences

 

  • Project management of the clinical section (M5) of BLAs prepared in the eCTD format

 

  • Establishment of a professional document writing culture in entrepreneurial environments

 

  • Training in what is expected and required from documents aimed for submissions to authorities

 

  • Development of processes and standard operating procedures

 

  • Quality review services to provide consistency, clarity and completeness to your regulatory and other documentation

 

 

 

 

 

 

                      

 

 

Documentum is owned by

Ulla Jessen, MSc (Cell Biology).

 

Holds a track record of success in the medical writing field, familiarity with data flow/processes from CRF to submission and a positive "can do" attitude.

Documentum

Rosenvangets Hovedvej 46.02, 2100 Copenhagen

tel: +45 29123040 Email: ulla@medicalwriter.dk cvr: 32631207