Acting with honesty, transparency, and ethical behaviour in all business dealings.
Putting the customer at the centre and consistently striving to exceed their expectations and deliver best service.
Taking full ownership of actions, being consistently responsible, and reliably delivering on all commitments.
Valuing diversity, treating others with dignity, and fostering an inclusive environment.
We are passionate about GxP quality, regulatory compliance, and pharmacovigilance, driven by a genuine love for what we do. This passion fuels our commitment to deliver tailored, high-quality consulting and audit solutions that help you build a robust, well-regulated environment. Our goal is to support your business in maintaining compliance, mitigating risks, and achieving sustainable success.
Years of hands-on experience in GxP quality management, GMP/GDP compliance, regulatory audits, and pharmacovigilance services enable us to confidently navigate complex challenges while serving clients across Europe and North America, proactively mitigating patient safety risks, ensuring global regulatory compliance (FDA, EMA, MHRA), and delivering inspection-ready solutions that enhance overall quality and customer satisfaction.
We provide independent GMP and GDP audit services for pharmaceutical manufacturers, wholesalers, and distributors. This includes internal audits, supplier and vendor audits, mock inspections, and regulatory gap assessments aligned with EU GMP, EU GDP, MHRA, EMA, and FDA requirements.
Yes. We support regulatory inspection readiness for MHRA, EMA, FDA, and other global regulatory authorities, including mock inspections, documentation review, staff interview preparation, and post-inspection remediation and CAPA support.
Absolutely. We deliver end-to-end GxP consulting services across GMP, GDP, and GvP, supporting quality system design, implementation, optimisation, and ongoing compliance monitoring for life science organisations.
Yes. We specialise in QMS design, implementation, optimisation, and remediation for pharmaceutical and medical device companies. Our QMS solutions align with ICH Q10, EU GMP, ISO standards, and regulatory authority expectations to ensure systems are scalable and inspection-ready.
Yes. We conduct pharmacovigilance audits and GvP compliance assessments for Marketing Authorisation Holders (MAHs) and service providers, covering PV systems, safety governance, vendor oversight, and regulatory compliance.
Yes. We provide EU Qualified Person for Pharmacovigilance (QPPV) services, national QPPV or pharmacovigilance contact person services, as well as ICSR processing, literature searches, and E2B and non-E2B regulatory submissions.
Yes. We support CAPA management, root cause analysis, and remediation planning following GMP, GDP, and GvP audits or inspections, ensuring effective regulatory responses and sustainable compliance.
Yes. We provide independent quality oversight and strategic quality consulting for small and mid-size pharmaceutical companies, offering flexible expert support without the cost of maintaining a full in-house quality team.
Yes. We deliver practical training on GMP, GDP, GvP, and quality best practices, tailored to your organisation’s products, processes, and regulatory risk profile.
We support clients across European countries, North America (United States and Canada), and India. Our services in these regions include pharmacovigilance, GMP, and GDP quality and compliance support, delivered in alignment with EMA, MHRA, FDA, and other global regulatory authority requirements.
Partner with us to elevate your quality systems, ensure compliance, and drive meaningful business transformation.
Built with passion and purpose. Helping you grow smarter, not harder.
