Compliance support for CMOs and CDMOs
Compliant pharma manufacturing
Our expert consultants support Contract Manufacturing Organisations (CMOs) and Contract Development & Manufacturing Organisations (CDMOs) in navigating responsibilities and challenges, ensuring compliance, efficiency, and competitive advantage.
Fulfilling regulatory and quality responsibilities as CMO/CDMO
We provide tailored guidance in regulatory strategy, quality assurance, and Chemistry, Manufacturing, and Control (CMC), helping contract manufacturers exceed client expectations while meeting the highest regulatory standards.
By working with our specialists, CMOs and CDMOs can streamline regulatory submissions, enhance GMP compliance, and optimise quality management systems. Our support helps minimise risks, improve operational efficiency, and strengthen business relationships with MAHs and regulatory authorities.
We ensure that you meet all your regulatory and quality responsibilities:
Regulatory compliance & GMP adherence
- Maintain compliance with EU GMP, UK MHRA, Swissmedic, and FDA regulations.
- Prepare for and manage GMP inspections by regulatory authorities and client audits.
- Ensure adherence to regulatory guidelines for development, manufacturing, and quality control.
Quality Assurance & risk management
- Establish and maintain a robust Pharmaceutical Quality System (PQS).
- Ensure compliance with Quality Agreements between the CMO and MAH.
- Manage deviations, Out of Specification (OOS) results, and Corrective and Preventive Actions (CAPAs).
CMC & regulatory support
- Ensure compliance with Chemistry, Manufacturing, and Controls (CMC) requirements.
- Manage product and process changes while maintaining regulatory compliance.
- Provide necessary documentation for Marketing Authorisation Applications (MAAs) and variations.
Client & supply chain management
- Ensure timely and compliant product supply to MAHs.
- Manage supplier qualifications, raw material sourcing, and GDP compliance.
- Align production schedules with client expectations while mitigating supply risks.
Market Access & serialisation compliance
- Ensure compliance with the Falsified Medicines Directive (FMD) for serialisation and traceability.
- Support product packaging and labelling to meet market-specific requirements.
- Facilitate smooth market entry for client products.
Pharmacovigilance & product safety
- Ensure compliance with Good Pharmacovigilance Practices (GVP) if handling pharmacovigilance services.
- Report any adverse events to the MAH as per contractual agreements.
- Support regulatory authorities in pharmacovigilance-related inspections.
Your contact person
Erik Hedner
