Our Service Portfolio
Qualified Person Services
Independent QP support for commercial and clinical medicinal products, including batch certification, batch disposition review, deviation and investigation assessment, management of quality issues, and support during regulatory inspections. Services can be provided on a retained, interim, or project basis to meet both routine and business-critical requirements.
GMP Compliance & Gap Analysis Consulting
Practical, risk-based assessment of quality systems, procedures, and operational practices against current GMP requirements. Support includes gap analysis, inspection readiness programmes, remediation planning, compliance improvement projects, internal audits, and advice on regulatory expectations to help organisations maintain a sustainable state of inspection readiness.
Pharmaceutical Training
Tailored training programmes designed to improve GMP knowledge, quality culture, and regulatory awareness across pharmaceutical organisations. Training can be delivered for individuals or teams and covers topics including GMP fundamentals, quality systems, deviation management, investigations, data integrity, batch certification, inspection preparedness, and QP responsibilities.
Trainee QP Mentoring
Structured mentoring and development support for pharmacists and scientists progressing towards QP eligibility and registration. Guidance is provided across the QP study programme, practical experience requirements, interview preparation, GMP knowledge development, and the application of regulatory principles in real-world manufacturing environments.
Qualified Person Expertise
With 30+ years of experience in Pharmaceutical Quality roles across a variety of dosage forms and 16 years experience of pharmaceutical batch release, our Qualified Person possesses extensive certifications and the hands-on experience you need.
Experience of regulatory authority inspections from MHRA, FDA, HPRA, TFDA, EMA, etc.
We believe in the importance of being present on site, rather than working remotely, in order to fully comply with the QP's responsibilities.
Comprehensive Quality Assurance
Delivering end-to-end quality assurance consultancy, we meticulously perform batch certification, internal audits, and quality risk assessments while advising on improvements to uphold and elevate your pharmaceutical manufacturing compliance and operational excellence.
Explore Our Pharmaceutical Consulting Services
Contact us to learn about our Qualified Person services, regulatory support, and quality assurance consulting.