Kodiak Strategic Consulting
Consulting firm focused on the pharmaceutical and biotechnology sectors offering strategic business planning, regulatory and clinical development support, drug development and commercialization advisory, fundraising and litigation-support services. Services span early-stage through fully integrated company needs including CMC, preclinical and clinical development, regulatory submissions, and market/commercial strategy.
Industries
Nr. of Employees
small (1-50)
Kodiak Strategic Consulting
Plymouth, Minnesota, United States, North America
Services
Advisory and support for seed funding, angel investing, investment due diligence and institutional investment assistance.
Development of business plans, strategic planning, virtual management team support, project management, product licensing and due diligence.
Operational, supply chain and financial guidance for product launch and commercialization, plus market analysis and compliance support.
Oversight of due diligence for in-licensing, support for drug discovery research, formulation development and preclinical pharmacology/toxicology.
Litigation management, expert testimony on pharmaceutical patent, antitrust and product liability matters, mediation and arbitration services.
Regulatory and clinical strategy development, regulatory submissions, clinical product development, medical writing, and DSMB/CXO services.
Advisory and support for seed funding, angel investing, investment due diligence and institutional investment assistance.
Development of business plans, strategic planning, virtual management team support, project management, product licensing and due diligence.
Operational, supply chain and financial guidance for product launch and commercialization, plus market analysis and compliance support.
Oversight of due diligence for in-licensing, support for drug discovery research, formulation development and preclinical pharmacology/toxicology.
Litigation management, expert testimony on pharmaceutical patent, antitrust and product liability matters, mediation and arbitration services.
Regulatory and clinical strategy development, regulatory submissions, clinical product development, medical writing, and DSMB/CXO services.
Expertise Areas
- Clinical trial management
- Regulatory compliance and strategy
- Drug discovery and preclinical development
- Formulation development and CMC
Key Technologies
- Formulation science
- CMC and scale-up
- Preclinical toxicology assays
- Bioassay methods
News & Updates
Blog post describing a favorable conclusion in a breach of contract litigation matter and related expert involvement.
Article discussing damages in pharmaceutical patent matters following at-risk launches.
Lecture summary and materials presented addressing Hatch-Waxman and antitrust implications for pharmaceutical innovation.
Analysis and recommendations following a Phase 1 clinical study incident, from a drug development perspective.
Article referencing a bioassay technique used in pharmacological research.
Blog post describing a favorable conclusion in a breach of contract litigation matter and related expert involvement.
Article discussing damages in pharmaceutical patent matters following at-risk launches.
Lecture summary and materials presented addressing Hatch-Waxman and antitrust implications for pharmaceutical innovation.
Analysis and recommendations following a Phase 1 clinical study incident, from a drug development perspective.
Article referencing a bioassay technique used in pharmacological research.