Aim Higher with Peak BioConsulting
Peak BioConsulting offers strategic solutions to biotech and pharmaceutical companies in drug development, regulatory strategy, and due diligence.
Our Vision
We offer strategic consulting for regulatory filings and CMC development of biologics, gene therapies, and small molecules, with expertise in product safety, quality and efficacy.
Find out how our expertise in analytical development, CMC, and regulatory strategy can benefit your company, and let us help you navigate the complex regulatory landscape.
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.
Regulatory Filing Strategy & Execution
CMC Strategy & Technical Leadership
Analytical Development & Validation
Product Lifecycle & Commerical Readiness
CDMO/CRO Oversight & Tech Transfer
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.