- Are you at the preclinical stage of product development?
- Planning for or responding to regulatory filings and feedback related to your preclinical product characterization dossier?
- Preparing to do clinical trials or go to market?
- Or preparing technical due diligence for an upcoming merger, acquisition or in-licensing opportunity?
CY Preclinical Consulting provides you with strategic technical expertise and guidance.
We will help you advance development of your combination product solutions to market, providing solutions to enhance healing for patients.
Preclinical Strategy
SME Technical Consulting
GMP Biologics Manufacturing
Our Consulting Services
Practical scientific advice. Product-focused strategies.
Preclinical Strategy
- Biologic/Device Combination Product Development Strategy
- Amniotic Tissue Allograft Strategy
- GLP/non=GLP Preclinical Study Design and Oversight Solutions
- Formulation & Laboratory Product Characterization
SME Technical Consulting
- Regulatory Filing Support (technical writing, data positioning, agency interactions)
- Sales/Marketing Support
- Mergers, Acquisitions, In-Licensing Technical Due Diligence
GMP Biologics Manufacturing
- Recombinant Proteins
- Cell Therapies
- Technical Transfer
Preclinical Strategy
“Concurrent” vs linear development strategies.
We’ll help you identify strategic product development efficiencies.
Biologics / Device Combination Preclinical Strategy
What preclinical studies do you need to conduct today? Which can you commit to executing in parallel with your clinical trials? Or as a post-marketing approval commitment?
- IDE/IND-enabling strategies
- PMA/BLA-enabling strategies
- R&D budgeting and project planning
- Positioning preclinical/non-clinical data to enhance your regulatory filings
- Individual component (biologic and medical device) and combined product characterization guidance
- Single entity and packaged component product strategies
- Expertise in recombinant proteins, cellular therapies and human amniotic tissues in combination with biomaterial device components
Preclinical Study Design and Planning
- Biologic/Device Combinations
- Study design considerations important for Biologic/Device combination product safety/effectiveness studies
- In vivo biologic release kinetics from device components
- Biologics
- GLP toxicology/safety- acute, sub-chronic, chronic, repeat dosing, reproductive, carcinogenicity, tumorigenicity models
- PK/ADME- radiologic and non-radiologic approaches
- Preclinical models to evaluate orthopaedic bone and tendon repair, dermal wound repair, vascular repair and tissue vascularization, cardiac muscle repair
- Preclinical models of delayed healing
- Protein, cell and tissue characterization assays for strength, identity, biopotency, purity and processing residuals
- Cell-based bioassays
- Immunogenicity testing
- Medical Devices
- GLP Biocompatibility testing -ISO 10993 including Genotoxicity, Mutagenicity, Intramuscular Implant, Bioresorption, Systemic toxicity, Dermal irritation, Delayed hypersensitivity, Hemocompatibility, Cytotoxicity, Pyrogenicity
- Cell therapies
- In vivo cellular persistence and migration
- Immunocompromised preclinical models
- Cell-based bioassay models
- Master and Working cell bank characterization
- Immunogenicity
- Preclinical CRO identification/interactions
Formulation & Laboratory Product Characterization
- Product formulation studies
- IFU development studies
- Component Mixing, Homogeneity, Biologic stability, Thermal stability, Biologic potency, In vitro release kinetics
- IFU development studies
SME Technical Consulting
We’ll provide you with expert technical reviews, writing, and support.
Preclinical/Non-clinical writing and data positioning
- IDE, IND, PMA, BLAs
- Technical responses to regulatory feedback (eg. CRLs, ongoing regulatory interactions)
- SME technical support for your product at regulatory interactions/meetings
Sales & Marketing Support
- SME technical writing (white papers, marketing materials)
- SME presentations of product science to customers
Due Diligence
- Technical review in support of mergers, acquisitions, product in-licensing opportunities
- Technical advisement to investors/venture capital
- Product science overviews and technical reviews
GMP Biologics Manufacturing
We’ll provide you with technical support for your specialized manufacturing needs.
- Biologics technical transfer strategy
- CMO identification/interactions
- Quality By Design approaches
- Technical study and validation strategies
CY Preclinical Consulting 