Trilogy writers are all degree-trained scientists and skilled in preparing documentation for any therapeutic area and indication. We write for a global clientele, from small biotech companies to multinational pharmaceutical companies and clinical research organisations (CROs). Our expertise comes from years of experience working in all phases of clinical development, which brings the depth of understanding needed to effectively communicate specific messages for varied documents. We are equally at ease writing about pharmacokinetics and pharmacodynamics as we are writing reports of clinical efficacy and safety or epidemiology. In addition to our experience in conventional drug therapies and medical devices, we have experience in novel therapies, including stem cells and other cell cultures, parasites, and gene therapy (mRNA) treatments.




We have written hundreds of documents in the following therapeutic areas and can bring the benefits of this extensive experience to your particular indication:

Anti-infectives Behavioural health Blood products/Haematology Cardiology Congenital Disorder Dermatology Endocrinology/Metabolism Immunology Neurology/Central Nervous System (CNS) Oncology Ophthalmology Orthopaedics

Paediatrics Pain Control Psychiatry Reproductive Medicine Respiratory/Pulmonary Rheumatology/Arthritis Skeletal disease Urology Vaccines Virology Women’s Health/   Gynaecology

Phase 1, 2, 3, and 4 All Types of Submissions Responses to Authorities Agency Hearings/Meetings Pharmacokinetics (PK) &   Pharmacodynamics (PD)

Biotech Biologics Devices Observational Studies Orphan Drugs Quality of Life

The new European Union Cosmetics Regulation No. 1223/2009 (which comes into force on 11 July 2013) sets out detailed requirements about documents that must be produced by companies marketing cosmetic products; and be available at all times for the regulatory authorities. The new documents include the Cosmetic Product Safety Report (CPSR) and an updated version of the Product Information File (PIF).

With extensive experience from the established world of pharmaceutical clinical documentation, and having tracked the development of the new Cosmetics Regulations, Trilogy is well placed to support the cosmetics industry in meeting your new obligations. We know how to present the necessary information, how to crystallise the messages and how to tell the story of the product in a clear, complete, easy to understand and consistent manner, minimising the number of questions that can arise when regulatory assessors process your documents.




Trilogy writers are fully conversant with International Conference on Harmonisation (ICH) and Good Clinical Practice (GCP) standards as well as European, US, and other local regulatory requirements and all our documentation complies with these standards.




Trilogy has extensive experience in preparing clinical documents and Common Technical Document (CTD) submissions. Regulatory documentation is our focus. Each dedicated team at Trilogy has more than 20 years of cumulative experience writing clinical documentation for the global pharmaceutical industry. We have written hundreds of Clinical Study Reports for all phases of clinical development and most indications. We have planned and prepared dozens of CTD submissions, from straightforward local variations to complex global submission dossiers for multiple indications.




Trilogy is used to producing information for every audience – from disease or drug information for patients to promotional / training material for the pharmaceutical industry and presentations for scientific conferences or KOL (Key Opinion Leader) meetings. We understand how important it is to pitch your message at the right level and in the right way.