We support structured investigation of deviations, non-conformities and audit findings. Our consultants help define effective root cause analyses, implement CAPA’s and monitor effectiveness to ensure continuous improvement.

We assist in setting up and managing change control processes to assess, document and approve changes that may impact product quality or regulatory compliance, ensuring traceability and oversight across departments.

We help set up or improve complaint handling systems to ensure timely intake, investigation, documentation and follow-up of product complaints, in compliance with applicable regulations (e.g. GMP, MDR, IVD-R).

Our experts support the design and review of Master Batch Records and batch documentation. We ensure accuracy, completeness and compliance with internal procedures and regulatory requirements, supporting both manual and digital systems.

We evaluate your existing QMS against relevant standards (e.g. GMP, GDP, ISO 9001, ISO 13485) and support the implementation or remediation of quality systems, adapted to your organisation’s scale and maturity.

We write and revise controlled documents such as SOPs, Work Instructions, Quality Manuals, Annual Product Reviews (APRs) and Product Quality Reviews (PQR/APQR), ensuring clarity, consistency and audit-readiness.

We help design and execute training programs tailored to your quality roles, including onboarding, GMP refreshers and role-specific qualification matrices. Our approach ensures regulatory compliance and a culture of quality ownership.

We support internal audits, supplier audits and regulatory inspections (e.g. EMA, FDA, Notified Bodies). Our consultants can perform audits, prepare documentation, train staff and guide you through CAPA closure.

We support regulatory affairs activities to help you gain and maintain market access. Our consultants assist in compiling, reviewing and submitting regulatory dossiers for product approvals in Europe, the US and other global markets. This includes preparation of CTD modules, variation filings and responses to authority questions, ensuring alignment with EMA, FDA and other regulatory bodies throughout the product lifecycle.

We support qualification and monitoring of suppliers, contract manufacturers and service providers. This includes audit planning, questionnaire development, risk assessments and performance reviews, ensuring supply chain compliance.

We implement risk-based thinking throughout your QMS: from deviation handling to supplier qualification. Our consultants apply tools such as FMEA and risk matrices in line with ICH Q9 and ISO 14971 (for devices).

We provide experienced QA professionals who can take on batch record review, deviation closure and batch release responsibilities, ensuring your products meet all required specifications and compliance standards before reaching the market.