The team offers a full range of writing, reviewing and editing services.
We also offer a bespoke service and we are just the Company to help if you have something a little different in mind.
MEDICAL WRITING: Clinical Materials, Regulatory Writing and Medical Communications
Extensive experience in writing and other relevant roles
2015: Advanced Level Multidisciplinary Certificate
European Medical Writers Association (EMWA) attained
Continuous Professional Development Programme participation
All phases of clinical trials
Other clinical studies including real world experience (RWE), health economics and observational studies.
Wide range of materials from clinical trials to high-level components of regulatory submissions.
Medical Affairs and MedComms
Wide range of materials including manuscripts, slide presentations, web content
Click here to see examples of clinical materials, regulatory writing and medcomms materials.
Core Data Sheet Development and Labelling Compliance
- Working to develop wording in prescribing information for products in development and post marketing.
- Contributing to the writing, reviewing and updating of SPCs, labelling, prescribing leaflets and patient information leaflets.
- Contributing to the development of your core data sheets, review cycles and any changes required throughout continued pharmacovigilance.
- Making sure labelling of products is in line with Company Core Data Sheet and consistent with internal company labelling requirements and procedures.
- Advising and assisting you in your responses to regulatory authority queries and reviewing related position papers and justification documents (where applicable).
- Advising as consultants on processes to ensure effective safety and efficacy reviews.
- Initiating, developing and establishing improved processes and ensuring engagement across a global business.
Contact us to see how we can help you.
Other Life Sciences
Educational and Training Materials
- Advisory board or Steering Committee Minutes.
- Standard or privileged & confidential meeting minutes.
- International guidelines/ high level SOPs.
- Newsletters on products, projects or business initiatives.
- Explaining difficult concepts. Motivational communication.
- Our solid scientific background and experience adds value.
- Substantive editing, light editing or proofreading.
- Rewriting support for non-native English authors.
- ‘Document doctor’ – helping with word count issues, ‘writer’s block’ etc.
These are not exhaustive and if your needs are not itemised above please contact us to see how we can help you.