Our services

A full medical writing service

We offer a full medical writing service to cover your regulatory and medical communication needs throughout the lifecycle of your product, from preclinical development to registration and post-approval.

> flexibility
and friendly
attitude
> high
quality
documents
> Strict
adherence
to timelines
> high
quality
documents
REGULATORY DOCUMENTS

CLINICAL TRIALS

- Protocols & informed consent forms (ICF)
- Investigator brochures (IB)
- Investigational medicinal product dossiers (IMPD)
- Registry postings (EudraCT, clinicaltrials.gov)
- Clinical study reports (CSR) and patient narratives


REGISTRATION

- Briefing packages
- Module 2 of the common technical document (CTD)
- Responses to regulatory authorities’ questions
- Integrated efficacy & safety summaries (ISE and ISS)
- Risk management plans (RMP)
- Orphan designation application



MEDICAL COMMUNICATIONS

- Publications
- Literature reviews
- Slides, posters & abstracts
- Meeting reports
- Brochures & monographs
- Websites & press releases
- Medical education materials
- Training courses in medical writing

PRICING AND REIMBURSEMENT

- Core value dossiers
- Systematic reviews
- Joint briefing books (regulatory authorities and payers)

MEDICAL DEVICES

- Clinical evaluation reports (CER)
- Clinical investigation plans (CIP)
- Clinical investigation reports (CIR)