CMC

Alongside structured CMC project and program management, Concuir provides technical services that reinforce operational excellence and reduce risks for our clients:

Concuir facilitates vendor selection by managing the RFP process, evaluating proposals, and aligning with client priorities. We act as a central liaison to ensure vendors meet technical, quality, and budget requirements, supporting long-term success.

• Manufacturing site audit
• User representative during manufacturing
• Batch record technical review (pre and post-execution review and sign off)

Concuir consultants assist in reviewing deviations and corrective and preventive action (CAPA) reports, providing structured oversight for investigations. Our support ensures issues are resolved quickly, root causes are identified, and preventive measures are effectively implemented.

We also offer the option of on-site manufacturing oversight and technical representation during CDMO production campaigns by placing experienced consultants to serve as your user’s representative. Acting as an extension of your internal team, our consultants embed directly within the CDMO environment to bridge communication, troubleshoot technical issues in real-time, monitor critical operations, and ensure adherence to process and quality standards.

Our consultants also support batch record review to ensure accuracy, compliance, and completeness before signoff. This provides an additional layer of quality oversight, reducing the chance of costly errors or delays in manufacturing.

Concuir provides support for clinical formulation development across all phases of early drug development. Our team includes PhD-level formulation scientists with decades of hands-on experience in developing, optimizing, and troubleshooting formulations for drug products.

We work alongside our clients and their partners to ensure formulations are robust, stable, and scalable, supporting seamless transitions from lab-scale through clinical manufacturing. Whether developing a new formulation or refining an existing one, Concuir helps teams make informed, data-driven decisions that support both performance and manufacturability.

Concuir provides comprehensive project management and technical subject matter experts for technology transfers of manufacturing processes between facilities, organizations, and global sites. Our consultants act as liaisons between sending and receiving teams, facilitating seamless knowledge transfer including technical document writing, while maintaining alignment across quality, regulatory, and operations functions.

Beyond project oversight, our consultants directly assist with compiling data, drafting key sections, and managing timelines for IND submissions. This ensures regulatory readiness and reduces the risk of delays in clinical development.

Reliable shipping is critical across the entire product lifecycle. From analytical samples to clinical trial material and eventually finished product, our consultants provide oversight for both domestic and international shipments. We coordinate with vendors and logistics providers to help mitigate risks and maintain the integrity of shipped materials. We provide comprehensive inventory tracking across the vendors in your supply chain.

Our consultants lead CMC core team meetings on a consistent cadence, ensuring that cross-functional stakeholders remain connected and informed. By structuring agendas, tracking actions, and highlighting risks, we keep communication flowing across teams. The benefits of these core team meetings include:

• Clear, consistent communication between functions and vendors
• Alignment on priorities, responsibilities, and timelines
• Early identification of issues and risks before they become delays
• Establish a decision landscape and decision tracking to “stop the swirl”
• Greater accountability through structured action tracking and follow-up

Staying on schedule is one of the most critical elements of CMC operations. Our consultants are superusers of Microsoft Project, Smartsheet, and additional Gantt chart tools, enabling precise tracking of complex timelines across multiple workstreams. We provide:

• Development of integrated project schedules with clear dependencies
• Real-time visibility into critical path activities and bottlenecks
• Proactive adjustments to mitigate delays before they impact downstream activities
• Executive level product timelines
• Transparent reporting that keeps leadership and functional teams aligned

This rigorous approach ensures that programs stay on track, resources are used efficiently, and clients maintain confidence that deliverables will be met on time.