Analytical laboratory
FDA-registered analytical laboratory. Registration refers to the laboratory and is distinct from product approval.
- Method development, verification and validation
- Traceable analytical records and reporting
Rigor in the science. Clarity in the scope.
Scientific rigor, transparency, accountability and collaboration guide the way we work. Discuss the quality and documentation requirements specific to your program.
Phase-appropriate clinical manufacturing
Sterile and non-sterile clinical trial material support from preclinical development through Phase I and Phase II.
- Active quality oversight
- Documentation and traceability
- Process controls appropriate to development stage
A program-specific quality discussion
Align quality requirements, responsibilities and documentation before agreeing a scope.
- Audit and supplier qualification discussions
- Applicable methods and specifications
- Defined deliverables and communication
A TECHNICAL CONVERSATION STARTS HERETell us what your
Tell us what your
product needs to do.
Share your product, scientific challenge and next milestone. Request an NDA before providing proprietary details.