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:
Are you familiar with ICMC™: Initiative for Certification of Manufacturing Capabilities, delivered by DHC? ICMC is designed to close a critical gap in the CGT CDMO market by providing a level of transparency and trust that was otherwise lacking. ICMC also allows CDMOs to build credibility and differentiation in the marketplace while offering therapeutic developers a way to more robustly evaluate CDMO partners.
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:
Our foundational QMS framework enables smaller US-based start-up companies currently using an outsourced supply chain model (e.g. CDMOs and CTOs) to establish a phase-appropriate Pharmaceutical Quality System that utilizes recognized cloud-based electronic document and learning management systems (integrated EDMS-LMS) to enable release of Phase 1 GMP clinical trial material. This offering is a QMS framework of core documents and procedures which can be deployed within a quality-controlled space in a phase-appropriate, cost-efficient, user-friendly, scalable, and customizable manner, according to individual customer’s needs. This enables sponsors to initiate vendor qualification of GLP CROs, review and approve Quality Agreements, and conduct audits of CDMOs either by their own internal resources or a contracted QA resource provided by BTL.
Future plans include development of GLP and GCP SOPs, and a comparable framework designed to support early phase EU-based manufacturing.
Click the Request Consultation button at the top right to make an appointment to request this service.
Quality system remediation to address client concerns or regulatory findings can include gap assessment and reporting in addition to quality remediation plans and execution. This remediation can apply to any or all of the FDA Quality Systems approach: quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling.
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 in support of agency audits. We also plan and execute audits of 3rd parties (e.g., suppliers and contract testing/manufacturing sites) on behalf of client sponsors.
To ensure successful inspections, we conduct a risk evaluation well in advance of your inspection window. This assessment may identify high-risk areas in your supply chain, informing an inspection readiness plan and effective resource allocation. Inspection readiness also runs to gap assessment against the FDA System Approach, European and other international regulations, or more specialty regulations, like Annex 1 for sterile drug production manufacturing, data integrity compliance, or good laboratory practices.
As with our audit offerings, we also plan and execute these for 3rd parties upon request.
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:
