BBCR can assist clients in the following areas: Regulatory Strategy Thinking ahead during the regulatory process, we avoid unnecessary hurdles in the approvals process. We identify gaps, work through the right strategies for an effective product application, and prepare for label claims. FDA Meeting & Submission Critical to the success of bringing your product to […]
Tagged: regulatory phase
BBCR specializes in taking the complexity inherent to the regulatory phase of the approvals and simplifying it by strategizing our support to each client based on product-specific regulatory requirements and functional needs.
October 17th, 2022 | regulatory phaseCategories
- Biomarkers & Surrogate Endpoints
- Company News
- Drug Development
- Due Diligence
- Early Clinical Development
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- Medical Affairs and Clinical Research
- Miscellaneous
- Orphan Diseases
- Pre-IND
- Precision Medicine
- Rare Disease
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- Regulatory
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- Strategy and TPP
- Translation Medicine and Epigenetics
- Trial Management
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Recent Posts
- BBCR is highly experienced in developing innovative approaches to de-risk your product development during the early clinical development stage, including designing Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies. Learn more at bbcrconsulting.com #PoC #PoM #proofofconcept #proofofmechanism #earlyclinicaldevelopment #strategy
- BBCR partners with small and medium sized drug and device biotechnology firms. Our clients are clinical researchers and innovators looking for an efficient path to approval, and come to us from across the globe. Learn more about our consulting services at bbcrconsulting.com.
- From Preclinical through Phase I and POC studies, BBCR provides early clinical research services to enable informed, timely decision-making for our clients. We offer clinical, regulatory, translational, and biomarker consulting services that support our clients’ needs. Our process is designed to maximize time and cost efficiencies while mitigating risk.
- With Biomarkers a routine part of drug development, BBCR assists companies with the identification and adoption of biomarkers, especially valuable in rare disease and precision medicine product development.
- “The beginning is the most important part of the work.” — Plato. BBCR is dedicated to developing and nurturing a product’s unique strengths from conception to market. Our expertise with cell, biologics and gene therapy as they relate to rare disease is the cornerstone of our consultancy practice.