Writing, reviewing and editing

We cover a broad spectrum of Medical Writing, including regulatory and medical communication support throughout the lifecycle of a product, from preclinical development to registration and post-approval.
Extensive experience in writing and other relevant roles

2015: Advanced Level Multidisciplinary Certificate
European Medical Writers Association (EMWA) attained
Continuous Professional Development Programme participation

Clinical Research
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.

This is a key area because the documents and texts are the pinnacle of the regulatory process and form the basis of what you believe about your product; how your product can be prescribed safely and effectively; what can be said about your product and how it can be marketed. We can help you with:

• 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.

In addition to medical writing and clinical research we have technical knowledge and expertise in other categories of life sciences. Our specialties include carcinogenesis, genetic toxicology and DNA. We have worked on projects relating to veterinary and occupational health topics. Our sound scientific experience and adaptability equip us to tackle new subject areas with relish.

We offer writing, reviewing and editing services for your range of materials and formats. We can also help you by becoming involved in other learning activities.

• Advisory board or Steering Committee Minutes.
• Standard or privileged & confidential meeting minutes.
• International guidelines/ high level SOPs.

Writing Communications

• Newsletters on products, projects or business initiatives.
• Explaining difficult concepts. Motivational communication.

 

Technical Reviewing

• Our solid scientific background and  experience adds value.

 

Editing

• Substantive editing, light editing or proofreading.
• Rewriting support for non-native English authors.
• ‘Document doctor’ – helping with word count issues, ‘writer’s block’ etc.