top of page

Simply assuring quality compliance

Building pragmatic, phase-appropriate quality management systems for early-stage biotech and pharmaceutical companies — from first-in-human through to commercial launch.

​

With over 30 years of pharmaceutical industry experience and 15 years leading global QMS transformation at GSK, Compliance-Science brings senior-level expertise that is typically out of reach for growing organisations — delivered with the agility and personal engagement of a specialist consultancy.

​

Whether you need a QMS built from the ground up, a GMP audit of your contract manufacturer, a structured quality improvement programme, or regulatory training for your team — Compliance-Science provides the expertise to get it done.

 

What I Do​

​

  • QMS Design & Implementation — Building GxP and ISO-compliant quality management systems tailored to your stage of development, regulatory jurisdiction, and operational scale.

  • Clinical Quality Systems — Implementing GCP-compliant quality management for clinical CROs and sponsors, aligned with ICH E6(R3).

  • Regulatory Compliance Strategy — Gap assessments, remediation planning, and inspection preparation across FDA, EMA, MHRA, and TGA frameworks.

  • GMP Audit & Assessment — Independent audits of contract manufacturing organisations, sterile manufacturing sites, API producers, and biologics manufacturers against FDA, EMA, and ICH standards.

  • Quality Improvement Programmes — Leading structured programmes to remediate systemic quality gaps, restore inspection readiness, and embed sustainable quality culture.

  • Quality and Compliance Training — Bespoke training programmes covering GMP, GCP, ICH guidelines (including ICH E6(R3), Q9, Q10, Q12)

 

Who I Work With

Compliance-Science works with organisations across the healthcare sector, with a particular focus on:

  • Early-stage and mid-size biotech companies building their first GxP quality infrastructure

  • Pharmaceutical companies navigating regulatory submissions and Pre-Approval Inspections

  • Clinical CROs and sponsors requiring GCP quality system implementation or remediation

  • Contract Development and Manufacturing Organisations (CDMOs) preparing for regulatory inspection

  • Medical device companies requiring ISO 13485-aligned QMS design or gap assessment

bottom of page