Nonclinical drug development is essential for gaining valuable information regarding pharmacology, pharmacokinetics, and toxicity of new chemical entities, biologics, or reformulated drugs. These studies are performed explicitly to determine drug substance and/or drug product safety prior to testing in human subjects. Nonclinical testing requirements for a drug or biologic vary for the stage of development. Knowing when, where, and how to implement these programs is a critical consideration in integrated drug development. Nonclinical Program Design Regulatory Agencies require various nonclinical data at different times in the development process. Furthermore, while ICH guidelines provide structure to global nonclinical strategies, there are often regional nuances (EU, US, Japan) to study design and execution that must be considered. While nonclinical efforts are most often associated with reaching first-in-man studies, nonclinical programs run the lifecycle of the drug development process, and program progress is determined or dependent on the results. Swiftwater Group works with clients to design a customized program that best suits the needs of the product. We provide a full array of services as follows: Nonclinical Program Strategy Individual study design Protocol Design Dose Selection Animal model selection Special population requirements Vendor Recommendation for Selection RFP Process Competitive Bid Analysis Cost Assessments Regulatory and Quality Compliance according to 21 C.F.R. 58 QA of method validation for analytical and bioanalytical techniques Oversight of analytical and bioanalytical study data Project management services from protocol study generation to final report and submission CRO Selection and Management Swiftwater Group also works with clients to identify CROs that offers the best services specific to their nonclinical program design. We have experience working with a wide variety of service provides both inside and outside the US. Services provided include: Vendor Recommendation and Selection RFP Process Competitive Bid Analysis Cost Assessments Contract negotiation with selected vendor(s) Conduct site visits to vendor finalists, including GLP/QA inspections Project management services from vendor comparison and selection throughout study matriculation and completion Document Preparation and for Regulatory Review Upon completion of nonclinical studies, Swiftwater Group can provide services to summarize all necessary studies for inclusion into various regulatory submissions. The submissions include: IND, IMPD, and CTA Investigator Brochure (IB) NDA, BLA, MAA Quality Auditing and Audit Reports (GLP) Swiftwater Group can provide quality assurance services for GLP (21 C.F.R. 58) and all nonclinical and bioanalytical support labs. For more information, see our Quality Assurance Services page.