We support biotechs across the EU, UK and Switzerland with drug safety and medical writing services. We can help you maintain compliance and product safety throughout development and after authorisation.
Our services focus on the three documents that carry the most weight with regulators across the product lifecycle:
- RMP (Risk Management Plan)
- Clinical Trial Protocol
- CSR (Clinical Study Report)
- DSUR (Development Safety Update Report)
- PBRER (Periodic Benefit-Risk Evaluation Report)
Our Services
The quality of your regulatory writing directly affects how regulators perceive your product’s benefit-risk profile. We work as an extension of your team, drafting, reviewing and finalising key regulatory and safety documents to the standards expected by EMA, MHRA, Swissmedic and national competent authorities.
Development Safety Update Report (DSUR)
A well-organised, efficient safety reporting pathway is a pivotal requirement for product development – and it’s also an opportunity to save time and reduce study cost.
Once signed, safety monitoring plans are unlikely to be amended without incurring high costs. Our experts provide DSUR support across the full annual cycle:
- Submission support to EMA, MHRA and national competent authorities
- Drafting, reviewing and finalising annual DSURs on behalf of the sponsor
- Coordinating input from clinical, statistical and pharmacovigilance teams
- Ensuring consistency with the protocol, Investigator’s Brochure (IB) and Reference Safety Information (RSI)
Periodic Benefit-Risk Evaluation Report (PBRER)
PBRERs come under close scrutiny. Inconsistencies with other safety documents or weak benefit-risk assessment can result in regulatory action and time-intensive follow-up examinations.
Our regulatory medical writing team supports you with:
- Full PBRER authoring aligned with ICH E2C(R2) and EMA expectations
- Benefit-risk assessment, including integration of post-marketing and clinical trial data
- Synchronisation of DSUR and PBRER submission timelines
- PRAC and NCA response preparation
Risk Management Plan (RMP)
RMPs must remain consistent with company labelling and other safety documents, including the Investigator’s Brochure (IB), Reference Safety Information (RSI), Company Core Data Sheet (CDS) and periodic safety reports.
We project-manage the full RMP lifecycle:
- Aligning the RMP with PBRERs, DSURs and product labelling
- Authoring new RMPs to support MAA submissions
- Updating existing RMPs at variations, renewals and following safety signals
- Reviewing RMPs drafted by internal teams and providing regulatory-ready feedback
Integrated Safety Summary (ISS) or Clinical Summary of Safety
As regulators become increasingly rigorous in assessing pre-approval safety, the quality of the ISS/CSS often determines how smoothly an MAA progresses.
To avoid review delays, the ISS/CSS needs to be a uniform and comprehensive document regardless of the sources it draws from. Our team supports production, review and quality control of the integrated safety summary, so it stands up to scrutiny across regulatory agencies.
Benefit-Risk Assessment
Robust benefit-risk assessment underpins every key safety document, from the DSUR through to the PBRER and RMP. We provide structured benefit-risk evaluation support to ensure your reasoning is consistent across the product dossier and defensible at regulatory review.
Why Choose Pharma Design
If your team doesn’t have the resources to run regulatory medical writing and safety writing functions in-house Pharma Design can help you with:
- Experienced safety specialists with hands-on EMA, MHRA and Swissmedic experience on Clinical Protocol writing
- Coordinated DSUR, PBRER and RMP timelines that reduce duplication and rework
- Consistency across your safety documentation and product labelling
- Flexible engagements that scale with your clinical development stage
We also support clinical development strategy and clinical trial activities, including how safety reporting feeds back into protocol design and study conduct.
Speak to a Regulatory Medical Writing Specialist
If you are preparing a draft Protocol, CSR, DSUR, PBRER or RMP, or need broader drug safety services to support your development programme, we’re here to help.
For safety advice on pharmaceutical products, call us on +44 75579 83864, or complete our online enquiry form and one of our consultants will be in touch within 24 hours.
Our Values
The value we bring to pharmaceutical companies falls into four main areas:
- Objective, impartial advice tailored to your needs
- Help cut your development costs
- Help reduce your time to market
- Keep your drug on the market