Services

Your product is poised to transform the healthcare industry, benefitting patients and physicians alike. We are your partner in navigating the complexities of preclinical development to ensure that you can advance your product from concept to the clinic. We can support medical technologies of all risk classes including surgical, interventional, and combination products. With broad expertise across all facets of preclinical research, let us guide you through the execution of your preclinical evidence generation program to enable regulatory success.

List of Services

Preclinical Strategy Development

Preclinical testing plan tailored to your goals
GLP and non-GLP in vivo testing for all product development stages
Animal model selection and refinement
Research and clinical surgical expertise
Biocompatibility testing (ISO 10993-6) programs

Preclinical Study Management (GLP and non-GLP)

Contract Research Organization (CRO) due diligence and selection
Protocol development
Study oversight (non-QAU)
Review of study and Contributing Scientist reports
Relationship management with CROs and study Contributing Scientists

Regulatory and Technical Document Writing

FDA pre-submission (Q-sub) preparation and meeting participation
Preclinical data summaries for regulatory filings
Peer-reviewed publications, white papers, and other technical documents

Preclinical Due Diligence

Review and appraisal of preclinical data
Regulatory gap assessments

Scientific Support

Technical training (physician, sales team, educational)
KOL/scientific advisor identification, vetting, and selection
Research and business grant application support

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