We’ll work with you to
Design preclinical R&D strategies to advance development of your combination product candidates
Navigate biologic and medical device regulatory pathways to gain market approval
Our consulting services and decades of industry expertise help you advance your innovative patient solutions through the complexities of combination product development.
Practical scientific advice. Product-focused strategies.
CY Preclinical Consulting brings you a deep scientific understanding of biologics and medical devices, alone and in combination.
We pair this with a client-first, pragmatic commercial mindset to product development.
Our focus is to help you accelerate development and commercialization of your regenerative medicine products.
We propose practical, product-focused strategies, not “science for the sake of science”.
Your trusted consulting partner.
- 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?
As your consulting partner, you can trust us to adopt the strategic regulatory and commercial mindset needed to optimize your R&D efforts.
We will help you navigate the complex regulatory landscape of biologic/device combination products.
Our Services
CY Preclinical Consulting will provide you with strategic technical expertise and guidance.
Together we will advance your combination regenerative medicine solutions to improve healing outcomes for patients.
Our consulting services focus on helping your business in three main areas:
Preclinical Strategy
SME Technical Consulting
GMP Biologics Manufacturing
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
Our Areas of Expertise
Recombinant proteins, cell therapies, human amniotic tissue allograft biologics alone or in combination with device materials
Orthopaedics, dermal wound repair, sports medicine, vascular repair, dental tissue repair and other indications with unmet clinical needs
Commercial Product Experience
- AUGMENT® Bone Graft, AUGMENT® Injectable
- Recombinant Human Platelet-Derived Growth Factor-BB Combined with Beta-Tricalcium Phosphate Device Materials for Foot/Ankle Arthrodesis
- DERMAGRAFT®
- Human neonatal dermal fibroblast cells combined with a biodegradable polyester mesh scaffold for treatment of Diabetic Foot Ulcers
- Human amniotic tissue allograft products
- Amniotic tissue products for chronic/acute wound and surgical tissue repair
CY Preclinical Consulting 