The landscape of drug/device development is evolving rapidly. Let us find a solution that best fits your needs.
Be best-in-class or firs-in-class often needs a thorough landscape analysis and cost/ROI analysis. RMBio can leverage Competitive Intelligence, Probability of Success, and potential unexplored areas benefiting your business.
Services for Pharmaceutical Companies
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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
AI integration into pharma and drug development
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Preclinical & Clinical StrategyPreclinical & Translational Research
Novel modalities and scientific gaps for their development
AI integration in drug development (e.g. discovery, development, biomarker/PM, and clinical dev/ops)
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 device products (e.g. ISO 10993 and its gap assessment)
Pre-submission strategy and interactions with regulatory agencies
Regulatory strategy for emerging biotech platforms (CRISPR, gene therapy, cell therapy)
Support in GLP/GMP compliance
FDA and EMA regulatory consulting for preclinical and early-stage clinical trials
Risk assessment of immune-related adverse effects
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Product Development & Strategy
Optimization of formulation and delivery mechanisms for biologics
Analysis of mechanical, physical, and biological properties of drug delivery devices
Support in preclinical and clinical study design to maximize drug efficacy and safety
