The landscape of drug/device development is evolving rapidly. Let us find a solution that best fits your needs.
Biotech companies focus on innovation and developing cutting-edge solutions. Our expertise will support your R&D and commercialization efforts.
Biotech Industry (Startups, Small to Large Cap)
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Technology & Product Development
Feasibility assessment and optimization of biomedical devices
Evaluation of injectable & implantable biomaterials
Support in nanomaterial-based therapeutics (design, formulation, safety)
Development and testing of aesthetic and regenerative medicine devices
Immune response interpretation and mitigation in novel biotech therapies
Assistance in the scale-up process for biomaterials and nanotherapeutics
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Preclinical & Clinical Strategy
Design and implementation of preclinical models to assess efficacy and safety
Immunogenicity evaluation of biopharmaceuticals
Design of assays for toxicity and immune response prediction
Guidance on translational medicine approaches for drug-device combination products
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Regulatory & Quality Compliance
Biocompatibility compliance for biotech products
Pre-submission strategy and interactions with regulatory agencies
Regulatory strategy for emerging biotech platforms (CRISPR, gene therapy, cell therapy)
Support in GLP/GMP compliance
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Business & Commercialization Support
Technical due diligence for biotech startups
Identifying and overcoming market entry barriers
Competitive landscape analysis and business strategy formulation
