Aim Higher with Peak BioConsulting
Peak BioConsulting offers strategic solutions to biotech and pharmaceutical companies in drug development, regulatory strategy, and due diligence.
Our Expertise
We are dedicated to optimizing your regulatory pathway and streamlining the process to get your products to market efficiently and compliantly.
Discreet and confidential due diligence support whether for potential in-license/acquisition opportunities or preparation to host out-license.
CMC Strategy & Technical Leadership
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Strategic CMC planning aligned with clinical development milestones
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Risk assessment of raw materials, Critical Quality Attributes (CQAs), control strategy, process control parameters (CPPs), DOE, Specifications
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Inspection readiness and GMP compliance support
Regulatory Filing Strategy and Execution
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End-to-end support for IND, IMPD, BLA, and MAA submissions and post-marketing commitments
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Authoring and reviewing Module 3 (CMC) sections
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Regulatory response management and agency interactions (FDA, EMA, CVM)
Product Lifecycle and Commercial Readiness
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Support for pivotal-stage development and commercialization
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Registrational batch analysis and stability program design
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Drug-device compatibility and high-concentration formulation strategy
Analytical Development and Validation
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Phase-appropriate method development and validation (ICH Q2) for release testing, characterization assays, purity and potency assays, biophysical assays
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Specification setting, comparability assessments, and control strategy design
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Lifecycle management of analytical methods across modalities
CDMO/CRO Oversight and Tech Transfer
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Vendor selection, management, and performance optimization
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Method transfer and troubleshooting across global sites
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Quality-by-Design (QbD) integration and operational efficiency improvement
Therapeutic Areas
Oncology
Advancing targeted therapies and biologics with precision-driven CMC and regulatory strategies across solid tumors and hematologic malignancies.
Immunotherapy
Supporting innovative immune-modulating platforms through robust analytical development and global submission planning.
Gene Therapy
Guiding complex AAV and RNA-based modalities from early development to commercialization with deep technical and regulatory expertise.
Rare Diseases
Enabling accelerated development pathways for orphan indications through strategic CMC planning and agency engagement.