𝐖𝐡𝐚𝐭 𝐭𝐡𝐢𝐬 𝐜𝐨𝐥𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐢𝐨𝐧 𝐛𝐫𝐢𝐧𝐠𝐬:

𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐨𝐩𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐩𝐞𝐫𝐟𝐨𝐫𝐦𝐚𝐧𝐜𝐞 𝐚𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐨𝐟 𝐂𝐃𝐌𝐎 𝐟𝐫𝐨𝐦 𝐚 𝐬𝐩𝐨𝐧𝐬𝐨𝐫-𝐜𝐨𝐦𝐩𝐚𝐧𝐲 𝐩𝐞𝐫𝐬𝐩𝐞𝐜𝐭𝐢𝐯𝐞 goes far beyond classic GMP compliance. It entails evaluating a CDMO’s ability to reliably execute and scale for your specific product, identifying compliance, operational and organizational risks, and assessing the robustness of underlying operating systems. This expanded service is positioned and delivered through a 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐩𝐚𝐫𝐭𝐧𝐞𝐫𝐬𝐡𝐢𝐩 combining MK Bio Consultancy’s deep experience in CMC project management, technical transfers, vendor selection and operational strategy with AMK Compliance Insight’s expert quality assurance, compliance consulting, audit execution, and process improvement expertise.

𝐀𝐛𝐨𝐮𝐭 𝐭𝐡𝐞 𝐩𝐚𝐫𝐭𝐧𝐞𝐫𝐬:

MK Bio Consultancy is led by dr Marta Kijanka, PMP bringing experience from both biotech and CDMO environments. MK Bio Consultancy offers support in CMC project management, technical transfers, vendor selection and operational strategy.
AMK Compliance Insight is led by Anna-Myra Koopmans, Pharmacist, QP bringing decades of experience in pharmaceutical quality assurance, auditing and compliance consulting. AMK Compliance Insight supports organizations with audit execution, quality system strengthening and inspection readiness.

𝐖𝐡𝐲 𝐭𝐡𝐢𝐬 𝐦𝐚𝐭𝐭𝐞𝐫𝐬:

In a complex CDMO landscape, compliance alone is not enough. Sponsors need assurance that their contract partners can 𝐞𝐱𝐞𝐜𝐮𝐭𝐞 𝐨𝐩𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐚𝐥𝐥𝐲 at the level required for successful clinical and commercial manufacturing, from planning and quality systems to operational capabilities to execution and scalability.

Whether you’re evaluating a new CDMO partner, seeking a second source, or preparing for complex scale-up and transfer activities, this combined offering of MK Bio Consultancy and AMK Compliance Insight enables you to make more informed decisions and mitigate risks at every stage.