Let us guide you on the Path to Patients

Our Services

Preclinical & Regulatory Strategy

  • Design and deliver a preclinical activity roadmap

  • Exploratory and investigative toxicology strategies

  • Nonclinical study alignment with regulatory strategies

  • Nonclinical strategies to support clinical development plans and the proposed indication

  • IND-enabling toxicology study strategies and interpretation of results, including e.g., pathology, PK/PD, together with long-term and specialty toxicology evaluations

Business Development Strategy

  • Supply Chain

  • R&D Strategy

  • Market Access

  • Market Research

  • Sales and Operations

  • Opportunity Mapping

  • Business Analysis/Forecasting

  • Commercial Strategy/Marketing

  • Business Plans/Investor Pitch Decks

  • End-to-end Business Development expertise

  • Tailored development strategies to align with corporate goals

  • Technical expertise to support due diligence (buy side or sell side)

  • Functional capabilities to build valuations to inform management decisions and negotiation strategies

  • Alliance management to support ongoing obligations from signed partnerships

  • Negotiation strategies and deal execution for any type of corporate transaction (license/collaboration/M&A/etc.)

Commercialization & IP Strategy

  • Strategic IP support

  • IP/technology licensing

  • Business plan development

  • Spin-out company creation

  • Techno-commercial project appraisal

  • IP/project portfolio evaluation and triage

  • Economic Impact studies and project valuation

  • Review of effectiveness of translational research fund schemes

  • Organizational improvement of technology transfer and incubation services

Global Networking

  • Identification of potential partners

  • Management of the due diligence process

  • Preparation and maintenance of data rooms

  • Preparation of program materials to share with external parties

Project & Portfolio Management

  • Project Management

  • Innovation management

  • Study outsourcing and monitoring

  • Preclinical development plans and budgets

  • Project evaluations and due diligence support

Technical Writing & Assessments

  • Environmental Risk Assessments

  • Toxicological Risk Assessments for Impurities, Leachables & Extractables

  • Nonclinical overviews and preclinical parts of IB, IMPD, IND, etc.

  • Determination of Permitted Daily Exposure & Occupational Exposure Limits

  • Biocompatibility Assessments for Medical Devices (acc. to DIN EN ISO 10993)

Study Support

  • Pharmacokinetic and metabolism profiling

  • Nonclinical pharmacology and translational assessments

  • PK/PD modeling support and evaluate predictive models

  • Analysis and intpretation of resulting data at agreed milestones

  • Coordinate and oversee the outsourcing of laboratory nonclinical studies

  • PK/PD evaluation, preliminary human dose/exposure projections and safety margins

Consulting On-Demand

This approach is often appealing to customers who wish to leverage the resources and expertise of our consulting group for more short-term initiatives. A consultation engagement could include:

  • Guidance on regulatory requirements

  • Literature research and competitive analysis

  • De novo assay development, review, and execution

  • 3rd party vendor assessment, recommendations, and data review for CDMOs and CROs

  • Data analyses, interpretation, and high-quality advanced study reports

"Path2P was instrumental in guiding our preclinical and regulatory strategy. Their team delivered clear, actionable insights and felt like a true extension of our startup. Thanks to their support, we’re advancing with confidence toward our IND submission."

— CEO, BIOPHARMA STARTUP

Get started with Path2P, today.