Our industry-experienced experts have implemented dozens of quality systems within the biopharmaceutical, pharmaceutical, medical device, and combination product industries. We assist with organizational activities, plans, policies, procedures, and processes and provide the resources to design, implement, and maintain a quality system that delivers quality, compliant drug products.
We develop and implement quality systems in accordance with:
Our team designs and implements quality system procedures and instructions in line with client objectives and the requirements of the leading regulatory bodies. Elements of our quality management system programs include the establishment and/or management of:
Whether preparing for and supporting an external GMP audit by a global regulator [pre-approval inspection (PAI), pre-licensing inspection (PLI)] or planning and executing an internal audit, our team offers comprehensive capabilities.
Leveraging decades of experience, BioTechLogic supports comprehensive global inspection readiness remediation projects.
BioTechLogic assists companies by supporting the registration of drug-device combination products. BioTechLogic’s team can guide you through the matrix of requirements. The following are examples of services to help support combination products throughout product development and into commercialization: