Pacific BioLabs offers custom research and testing services in support of drug and biologic discovery and development, as well as support of medical device development. Our scientific staff can assist in the design and implementation of studies that meet specific compound or product development needs, while maintaining the required level of regulatory compliance.
Custom Preclinical Studies and Custom GMP Studies
Our support of client needs spans the life cycle of drug and device development, from implementation of client-specific pharmacology of efficacy models (non-GLP), to modification of standard in vivo studies in support of regulatory submissions (GLP), to support of manufacturing activities through bioassay for stability and microbiological test procedures for lot release (cGMP). All of these activities can be customized to suit the specific needs of a particular development project.
Pacific BioLabs supports these custom studies in multiple ways. We work closely with clients to transfer and implement their testing procedures at Pacific BioLabs and we also develop and implement client-specific procedures using our own highly qualified staff.
Certified and Accredited Services
All in vivo test procedures at Pacific BioLabs are vetted through our IACUC (Institutional Animal Care and Use Committee) and are conducted in our AALAC-accredited and USDA-inspected animal facility.