Our Services
We provide tailored drug safety advice and strategic guidance that supports biotech companies through every phase to comply with pharmacovigilance regulations from clinical trials to market launch and beyond. We focus on creating scalable, agile systems that allow our clients to retain oversight while outsourcing day-to-day operations efficiently.
Gap analysis, process development & process re-design
We understand how PV systems evolve as companies grow and need to adapt to different stages, from designing and building pragmatic PV systems that are fit for purpose.
Our experience is in building systems for client needs, rather than implementing a standard/generic process.
PV systems we have built and managed have been through numerous inspections and audits, including with the EMA, MHRA, HPRA, FDA and Health Canada.
We have audit qualifications and regularly run audits, helping us understand the variety of approaches to reach regulatory compliance.
We provide expert resource to assess the current landscape of a biotech in clinical development and conduct an in-depth assessment of current and future needs.
We assist with mapping out the infrastructure and processes needed to ensure a compliant and fit-for-purpose drug safety system is delivered.
We support the implementation of the proposed drug safety system by preparing comprehensive procedural documents to ensure clarity, compliance, and seamless execution.
We help our clients through the process of selecting an operational PV vendor.
We are experts at managing the Request for Proposal (RFP) process with multiple vendors and critically assess RFP responses to recommend the best vendor to suit our clients’ needs.
We have insight into pricing and commercial considerations across the sector.
With our knowledge of current industry PV technology, we assess how up to date vendor processes are.
Pharmacovigilance vendor selection & vendor management
Our team have decades of senior management experience in PV vendors, understand the different business and commercial models employed.
Our team have held senior roles at Marketing Authorization Holder companies and selected and managed multiple vendors.
We have done numerous RFP exercises for clients from biotechs to mid-sized branded generic companies.
We then helped clients on their PV journey, reviewing performance of existing vendors and retendering to find more cost-effective providers.
Our QPPVs have experience across over 30 companies and global territories, providing oversight of commercial strategies.
Scientific Writing
We define our clients’ strategic approach to drug safety, to support regulatory approval for their products.
We create the documents clients need to bring their products to market, such as Risk Management Plans and Pharmacovigilance System Master Files, Clinical Overviews and Clinical Expert Statements.
We conduct analysis to evaluate and report on drug safety, including signal detection and aggregate reports.
Across our team we have authored over 2000 reports cover a multitude of therapeutic areas, product types.
Our QPPVs have experience across over 30 companies and global territories, reviewing and approving scientific reports.
Experience in all complexity levels, with our scientific writing covering generic products to gene therapy, innovator and orphan products
Our team includes scientific experts with PhD’s in pharmacology, Doctor of Pharmacy and BPharm Pharmacy degrees.
Additional Services
Fractional Head of Drug Safety
Product acquisition & divestment
Preparation for sale/investment
New market entry / global expansion
Audits (GCP, GVP)
QPPV (EU and UK)
UK NCP provision
Inspection readiness
CAPA management
PSMF management