Addressing the multifaceted challenges of CMC requires comprehensive expertise and a coordinated approach. Our diverse, global team of CMC experts manages all technical and regulatory aspects of development, considering both FDA and European Health Authority guidelines.
Catering to (bio)pharma businesses of all sizes, we integrate with your team to facilitate product, process, and method development. Responsive and adaptable, we operate at the intersection of regulatory, scientific, and technical challenges, ensuring open communication with all stakeholders.
We react promptly and flexibly to your needs, acting as a high-quality extension of your team. Talk to us when you want to ensure efficiency, compliance, and success throughout your entire development journey.
Formulating CMC development strategy
Overseeing CMC Project Management
Preparing for agency meetings and responding to questions
Conducting technical CMC due diligence and gap analyses
Assisting with CDMO selection and management
Process Optimization
Performing GMP Audits and inspection readiness assessments
Providing Quality-by-Design (QbD) support, including Risk Assessments and Design-of-Experience (DoE) study design
Developing drug substance formulation
Designing manufacturing processes
Selecting packaging, including combination medical devices
We understand the unique CMC needs of (bio)pharma companies can often extend beyond the usual functional areas. The areas of expertise highlighted above form the core of our CMC support services. However, they don't define the limit of our capabilities.
If you require specialized CMC support in areas not explicitly listed above, we encourage you to reach out. Our seasoned team of experts is well-equipped to understand and address a wide spectrum of CMC-related activities and tasks.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.
