Our purpose is to help biotech innovators overcome the challenges of
drug safety.

We ensure that promising therapies reach patients while meeting the highest regulatory standards.

Our mission is to help biotech companies navigate drug safety regulations. We demystify pharmacovigilance, partnering with biotech companies in their growth phase from clinical trials into post-marketing, providing drug safety advice built on deep industry experience.

Understanding and globalising PV is hard. We simplify the complex.

ABOUT YOU

Our clients cover the range of biotech and pharma from the smallest biotechs to the largest global pharma groups.

  • Small & Emerging Biotech

  • Late-Stage Biotech

  • Established Biotech

  • Big Pharma

  • Generic Pharma

  • Specialty Pharma

Our speciality is Late-Stage Biotech. Clients that are reaching the pivotal phase of launching products in the European Union, US, Canada and the UK.

  • We understand the challenges of transitioning from clinical trials to post-marketing and help establish a robust pharmacovigilance infrastructure.

  • We cover all biotech drugs from traditional medicines as well as novel and rare therapies.

  • We cover all global regulatory regimes

We are drug safety architects

We take a holistic, strategic approach to designing and building robust drug safety frameworks.

We are experts in navigating global regulatory environments, enabling our clients to scale, innovation and grow.

We create tailored systems that match our client’s growth trajectory, aiming for drug safety to become a strategic asset, not simply a regulatory obligation.

Our services

  • Gap analysis, process development & process design

    Expert resource to assess the current landscape of a biotech in clinical development.

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  • Pharmacovigilance vendor selection & vendor management

    We help our clients through the process of selecting an operational PV vendor.

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  • Scientific writing

    We define our clients’ strategic approach to drug safety to support regulatory approval, with analysis to evaluate and report on drug safety.

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  • M&A and Growth

    Product acquisition & divestment advice

    Preparation for sale/investment

    New market entry / global expansion

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  • Support Roles

    Fractional Head of Drug Safety

    QPPV (EU and UK)

    UK NCP provision

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  • Quality and Audits

    Audits (GCP, GVP)

    Inspection readiness

    CAPA management

    PSMF management 

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  • Ireland is a home for 24 of the world’s top biotech and pharma companies.

  • Cambridge is Europe's largest biotechnology cluster, consisting of more than 30 science and technology parks within 10 miles of the city.

  • From globally recognised multinationals to transformational start-ups, The Oxford Science Park is a powerhouse for science and technology companies.

  • The Biotech City is a biotechnology and life sciences hub of the Metropolitan Montreal including world renowned biopharmaceutical firms and research institutes.

  • Greater Boston, primarily Boston and Cambridge, is home to more than 1,000 biotechnology companies, ranging from small start-ups to billion-dollar pharmaceutical companies. The many universities in the area give the region a large network of scientists.

We have a global footprint, with our team located around key biotech hubs.

We understand the challenges you face

  • We have designed and implemented Risk Minimisation Measures for gene therapies, innovator and hybrid products.

  • We have delivered successful Risk Management Plans for gene therapies, innovator and hybrid products.

  • We have led over 10 regulatory inspections (FDA, EMA, Health Canada) from planning to CAPA remediation and completion .

  • We have led over 150 drug safety audits.

  • Over 100 years regulatory pharmacovigilance experience across the Signal team.

  • Our team includes scientific experts with PhD’s in pharmacology, Doctor of Pharmacy and BPharm Pharmacy degrees.

  • We have experience in all complexity levels, with our scientific writing covering generic products to gene therapy, innovator and orphan products.

  • Authored and maintained essential clinical trial documents including protocols, Investigator brochures (IBs), safety monitoring plans and patient information materials.

  • Our QPPVs have experience across over 30 companies and global territories, reviewing and approving scientific reports.

  • Our team have held senior leadership roles at Marketing Authorization Holder companies and selected and managed multiple vendors.

  • We have authored over 2000 reports cover a multitude of therapeutic areas and product types.

  • We created the PV strategy and system for the first gene therapy approved in the European Union.

  • We have led clinical trials teams across Phase 1 start-ups in haematology, immunology and oncology.

  • We have led drug safety for investigator led trials to Phase 3 resulting in successful product approval.

Meet our team

  • Catherine Kenny

    Co-Founder and Managing Partner

  • Carly Gould

    Co-Founder and Managing Partner

  • Fionnuala Quinn

    Head of Client Relations

  • Anne Lucuta

    Principal Consultant

Get started with Signal, today.