Services

We offer comprehensive support for inspection readiness, assist with audit responses to National Authorities, and can coordinate the remedial measures necessary to fulfill commitments to both the FDA and EMA. Our services also encompass conducting third-party facility assessments, covering aspects including data integrity and alignment with current regulatory standards, including Eudralex Annex 1.

Our expertise includes performing mock audits and GMP assessments in compliance with US CFR 21, Parts 210 and 211, and EU Eudralex Vol 4. Our comprehensive audits can cover documentation, facilities and equipment, personnel and training, material management, manufacturing, quality control, supplier management, regulatory compliance, data integrity, and validation enabling us to identify any non-compliance issues and deliver actionable recommendations for corrective actions.

Quality Assurance (QA) services encompass deviation review and management, CAPAs, change management, and all phases of process development and manufacturing, from process design to commercial GMP production. We specialize in assisting clients in establishing and maintaining quality systems that fully comply with rigorous regulatory requirements and industry standards.

Process development encompasses assistance with upstream and downstream Quality by Design (QbD), process characterization, scale-up, and technology transfer, all aimed at enhancing efficiency, cost reduction, and ensuring product quality. We collaborate closely to develop and optimize processes that are robust, scalable, and compliant with regulatory standards.

Manufacturing services encompass the full spectrum of drug substance (DS) and drug product (DP) production, spanning from initial development stages to commercial manufacturing. We provide guidance on facility design, equipment selection, process validation and other critical factors to ensure successful production. Our technology transfer services help clients transfer processes and manufacturing operations to new facilities or external partners and Contract Manufacturing Organisations (CMOs).

Regulatory CMC services provide expert guidance in drug development, covering key milestones including IND, NDA, BLA, and MAA submissions. Our support extends to managing post-approval changes, ensuring a smooth regulatory process while maintaining compliance. With a comprehensive approach, we empower businesses to navigate the dynamic regulatory landscape and optimize product lifecycle management strategies.