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
- 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
- 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
- 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
- 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.
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)
- 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 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
Contact: info@scendea.com
Head Office address:
Scendea Ltd
20 The Causeway
Bishop’s Stortford, Hertfordshire,
CM23 2EJ
United Kingdom
Tel: +44 (0)1279 656 305
EU Office:
Scendea (NL) B.V.
De Cuserstraat 93
1081 CN Amsterdam
The Netherlands
Tel: +31 (0)208 949 169
US Office:
Scendea (USA) Inc.
Suite 110
5764 Pacific Center Blvd.
San Diego, CA 92121
USA
Tel: +1 619 793 4511
Fax: +1 858 295 1477
Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market and minimising development costs. A combination of scientific excellence, industry experience and a collaborative approach enable us to deliver high-quality innovative solutions, which allow our clients to succeed. Our international team offers strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory, which guide products efficiently from early development to marketing approval.