welcome to cereb biotech solutions!

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We help biopharma startups with navigating regulatory and clinical procedures by offering compliance support and chemistry, manufacturing, and controls planning.

our approach

pre-clinical planning

Biopharma startups usually feel overwhelmed and frustrated with compliance requirements, and want guidance in the clinical regulatory planning phase. We provide regulatory expertise and early strategic planning for FDA and IRB approval.

cmc strategy

Many therapeutic startups struggle with chemistry, manufacturing, and controls planning, particularly when scaling from research-grade to good manufacturing practice (GMP). We offer vendor selection and tech transfer strategy, alongside GMP readiness assessment.

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    Clinical and regulatory expertise

    For biopharma startups to develop excellent systems

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    biomedical research

    Committed to innovating medical research to provide life-saving treatments to patients

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    bioinformatics

    QMS platforms backed by AI for analysis and sharing of sequencing data

fda/irb support

Investigational Drugs and Devices (IND/IDE) and Pre-Market Approval (PMA)

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services offered

qms Setup

Quality Management System (QMS) support for early-stage compliance

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cmc strategy

Early-stage Chemistry, Regulation, and Controls strategy for biologics and coordination with Contract Development and Manufacturing Organization

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Let’s Touch Base!

Schedule a 1:1 introductory session with us to discuss your consulting needs.

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FAQ

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  • First things first, don't be nervous. We'll start with a consultation to determine your needs (and if we'll make great collaborators).

  • Pricing is based on both the project's scope and your desired timeline. (We promise fair rates and will always require your approval before we begin).

  • Timelines depend on the project, but I generally dedicate 3-6 months to each client, with the possibility of an extension based on the startup’s needs.

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