With over 20 years of national and international experience in Regulatory & Medical Writing covering most therapeutic areas, SBC is perfectly placed to provide expert support for all types of writing projects, even the most challenging.

We are an experienced, flexible team committed to producing the highest quality documentation, while making the process as simple and straightforward as possible for our clients. Our very high level of repeat business speaks for itself.

• We provide an expert team of medical, regulatory and scientific writers comprising industry-experience, PhD-level scientists and qualified physicians, all with excellent communication skills. 

• Our writers’ scientific, clinical and regulatory experience, as well as their therapeutic area expertise, ensures accurate, high quality, submission-ready documents. 

• We are recognized by our peers and our clients for our high standards of accuracy, clarity and consistency of messaging within and across all documents.

• All documents are prepared according to either an internal or client style guide, and follow a streamlined authoring and review process; all documents are subject to quality assurance review prior to release.

• We pride ourselves on our excellent levels of responsiveness to clients. We have ongoing and open communication with our clients and are ready to meet in person in addition to virtually.

We cover a wide range of therapeutic conditions with exceptional knowledge of the following areas:

• Bone health
• Cardiovascular Disease
• Dermatology
• Devices
• Diabetes
• Endocrinology
• Infectious disease/vaccines
• Oncology
• Psychiatry
• Respiratory health
• Rheumatology

We have provided our expertise to all types of companies, from large pharma, startup biotech, and the government in US and abroad. Please contact us to discuss how we can help you Get it right!

MEDICAL and CLINICAL WRITING

• Protocols
• Investigators’ Brochures (IBs)
• Lay Language Summaries for Clinical Trial Results
• Clinical Study Reports (CSRs)
• Patient narratives
• Development Safety Update Reports (DSUR)
• Periodic Safety Update Reports (PSUR)

SCIENTIFIC COMMUNICATIONS

• Manuscripts (including strategy discussions, literature review, summary tables and referencing)
• Abstracts, posters, podium presentations for scientific conferences
• Literature searches and summaries 
• Review articles
• White papers

REGULATORY WRITING

• Briefing Documents for Scientific Advice (EU) or US FDA Meetings
• Orphan Drug Designation and Maintenance supporting documentation (EU, UK and US)
• Investigation Plan (PIP / iPSP) supporting documentation (EU, UK and US)
• Early Access Pathway applications (PRIME (EU), ILAP/EAMS (UK), Fast Track (US), Breakthrough Therapy (US), QIDP (US), Regenerative Medicines Advanced Therapy RMAT (US)
• IMPD / CTA (EU, UK) and IND (US)
• Briefing Document for Innovation Task Force (EU)
• Regulatory responses to agency questions

MARKETING AUTHORISATION APPLICATIONS: CLINICAL AND NONCLINICAL DOCUMENTS

• Nonclinical Overview (EU / US)
• Clinical Overview (EU / US)
• Nonclinical Summary plus tabulations (EU / US)
• Clinical Summary plus tabulations (EU / US)
• Integrated Summary of Efficacy (US)
• Integrated Summary of Safety (US)
• Risk Management Plan (EU)
• Clinical Evaluation Reports (for EU / UK Medical Devices)

PRODUCT INFORMATION

• Product Information (USPI; EU SmPC, PIL; labelling)
• Core Data Sheet (Global)
• Patient Information Leaflet (PIL) for EU / UK
• Package labelling