Medical writing

Find providers of medical-scientific services: writing of expert opinions and expert statements on pharmacology and clinical studies, study reports, general medical-scientific texts, etc. The list does not claim to be complete and there can be no guarantee for the correctness and timeliness of the information provided. Furthermore, please note that this list does not have any recommendatory character.

If you are a provider of services in this area, you have the possibility to register free of charge in this directory.

Saidia Pharma Service Limited

Bei den Mühren 66a

20457 Hamburg

Germany

info@saidiapharma.de

Homepage 

  •     Expert Reports
  •     Environmental Risk Assessment (ERA)
  •     Reference Safety Information


Dittmann Medical Writing

Dr. Julia Dittmann

Seewartenstraße 10, Haus 2

20459 Hamburg

Germany

service@dittmann-medical-writing.de

Homepage

  • Modules of marketing authorisation documents, e.g. clinical overviews and clinical summaries
  • Summaries of product characteristics and product monographs
  • Study reports
  • Study protocols
  • Patient informed consent forms
  • Investigator's brochures
  • Documentation of scientific and clinical evidence of diagnostics


PAINT-Consult

Wenigenjenaer Ufer 12

07749 Jena

Germany

Phone: +49 3641 549396

Fax: +49 3641 549397

info@paint-consult.com

Homepage 

  • developing and optimisation of package leaflets, summary of product characteristics (SmPC), packaging materials and other medical information for healthcare professionals and patients; such as brochures, patient alert cards


Ramos Pharma Consulting

Schweidnitzer Str. 63

80997 Munich

Germany

yr@ramos-pharmaconsulting.de

Homepage

  • Patient information, package inserts
  • Study protocols (clinical studies and NIS)
  • Final study reports
  • Support of marketing in medical-scientific statements and target group-oriented communication of study data
  • Creation of slide decks, abstracts, posters
  • Production of medical and scientific texts for different target groups
  • Quality check medical accuracy of slide decks, advertising materials, publications, etc.


Diapharm GmbH & Co. KG

Hafenweg 18-20

48155 Münster

Germany

info@diapharm.de

Homepage

 

Clinical studies:

  • Development plans
  • Investigational medicinal product dossier (IMDP)
  • Investigator’s brochure
  • Final report

Marketing authorisation:

  • Expert reports on the pre-clinical section (CTD modules 2.4, 2.6, 4) 
  • Expert reports on the clinical section (CTD modules 2.5, 2.7, 5)
  • Review of study data, including literature research
  • Patient information leaflet (PIL)
  • Summary of product characteristics (SmPC)


ELC-Group s.r.o

Karolinská 650/1,

186 00 Prague 

Czech Republic 

info@elc-group.com

Homepage

 

  • Clinical Trials Documents (Protocols, Investigative brochure / Product Manual, Clinical study report (CSR), Investigational Medical Product Dossier (IMPD), Informed Consent Form, Case Record Form, Patient Diary)
  • Product Monographs
  • CTD Documents
  • Module 2.4 - 2.7 preparation as well as module 4 & 5 review
  • SPCs and PILs, Pack Inserts, Product Information
  • Gap Analysis of medical writing
  • Environmental Risk Assessment (ERA)
  • Abstract and Manuscripts
    - Posters, Presentations and Promotional tools
    - Scientific justifications, Biowaivers, Medical rationale
    - Safety narratives 


PharmaLex GmbH

Harrlachweg 6

68163 Mannheim

Germany

Homepage 

 

PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries. 

 

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.

 

The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

  • Clinical study concepts & outlines
  • Clinical study synopses
  • Clinical study protocols
  • Clinical study reports
  • Amendments to study protocols and study reports