Sylexis | Regulatory writing services for the pharmaceutical and medical devices industry.

Sylexis Limited was established in 2006 and offers regulatory writing services to the pharmaceutical and medical devices industries.

Sylexis specialises in the following:

Medical Devices

Clinical Evaluation Reports

Clinical evaluation reports (CERs) are written to MEDDEV 2.7/1 rev. 4 (2016) and Medical Device Regulation (MDR) 2017/745 standards. Sylexis has prepared numerous CERs – see the following examples:

Cardiovascular: devices for septal defects, mitral and aortic valves, coronary artery stents, heart failure;
Orthopaedic implants for cervical and lumbar spine fixation;
Inguinal hernia repair device;
Various surgical instruments;
Devices for gynaecological surgery;
Suture materials e.g. nylon, steel;
Skin wound closure materials;
Peripheral vascular stents and guidewires;
Medical software device;
Breast and liver tumour device;
Low level laser device for musculoskeletal and wound healing indications.

Literature Reviews

Literature reviews can either be stand-alone documents or part of a clinical evaluation report (CER). They are written to MEDDEV 2.7/1 rev. 4 (2016) and Medical Device Regulation (MDR) 2017/745 standards. Sylexis has written literature reviews for the following therapeutic areas: cardiovascular, peripheral vascular, orthopaedic, gynaecology, wound healing, ophthalmology, oncology, photodynamic therapy, photobiomodulation.

Scientific Validity Reports

Scientific validity reports are written as part of the performance evaluation report for in-vitro diagnostic devices (IVDs) in accordance with the In-Vitro Diagnostics Regulation (IVDR) 2017/746.

Pharmaceuticals

Clinical Overviews and Summaries

Clinical overviews (2.5) and summaries (2.7) are written as part of the Common Technical Document (CTD) for marketing authorisation application (MAA). Sylexis also writes combined clinical overviews and summaries to support MAAs for well-stablished use products. Sylexis has prepared clinical overviews and summaries for the following products:

Acne vulgaris treatment;
Non-steroidal anti-inflammatory drugs;
Pharyngitis treatment;
Photodynamic therapy for head and neck tumours;
Progesterone pessary used in assisted reproductive technologies;
Antifungal treatment;
Peptic ulcer treatment.

Safety Narratives

Sylexis writes safety narratives either as stand-alone narratives or as part of a study report. Narratives can be either tabular or free-text format. Sylexis has written stand-alone safety narratives to support obstetric and also renal failure indications.

Medical Devices & Pharmaceuticals

Clinical Study / Investigation Reports

Clinical study reports (CSRs) for pharmaceuticals are written to ICH-E3 standards and clinical investigation reports (CIRs) for medical devices are written to ISO 14155 standards. Sylexis has written numerous study reports, some examples as follows:

Phase I studies: phototesting of sunscreen products, pharmacokinetics of topical bacterial vaginosis product;
Phase I and III studies: treatment of P. falciparum malaria in adults and children in Asia and Africa;
Wound closure device;
Phase II ophthalmic treatments and devices e.g. glaucoma;
Colostomy device;
Intra-atrial septal device for heart failure.

Regulatory writing services for the pharmaceutical and medical devices industries.

Medical Devices

Pharmaceuticals

Medical Devices & Pharmaceuticals

Dr Gillian Pritchard

Interested?