We help you ensure that phase-appropriate compliant systems are in place so your program stays aligned with “Quality by Design” (QbD) principles and ahead of the curve—without wasting resources, capital, or generating excessive bureaucracy.
Visit BioTechLogic for additional Quality & Compliance services.
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.
We help you develop a Quality Management System (QMS) that meets the unique needs of your program and phase of development.
We analyze your existing QMS, identify any gaps, and provide phase-appropriate and resource efficient solutions to address those gaps.
We write your SOPs, policies, and other controlled documents, or provide expert review and revision of existing documents.
Hands-on operational quality support can take a variety of forms.
The generation and execution of a comprehensive phase-appropriate audit program is critical for regulatory and developmental success. DHC combines specialized in-house CGT experience and the use of a proprietary toolkit when customizing an audit(mock or otherwise) for your program.
We perform evaluations, risk assessments, and/or audits of critical raw material suppliers, contract manufacturers, and analytical service providers to ensure their quality standards are aligned with your needs.
Dark Horse eligible QPs are experts in global regulatory standards. Common eligible QP client requests include training and education on the roles of QP as well as QP audits and remediation. Please contact DHC for further discussion should you require batch certification or licensing support.
To provide support for a remediation or to ensure future compliance, we offer customized teach-ins designed to fit the scope of your needs.
Remediations are necessary in a variety of situations during the development timeline; common remediation responses may include a 483 remediation, clinical hold, a product complaint or adverse event, or Complete Response Letter (CRL).
For clients currently without internal leadership focused on this domain, senior DHC experts can provide interim expertise and leadership with the goal of enabling the clients to identify, hire, and onboard internal candidates in a timely manner.
