What We Do
Strategic Development Plan
At B4D we develop a Strategic Development Plan for your product that captures the excitement around your novel discovery with sufficient detail on commercial potential of the product for both investors and potential licensees. The plan will include a regulatory strategy for the lead indication and incorporate costs and timelines for preclinical, non-clinical, chemistry and manufacturing cost activities to the next major milestone.
Preclinical to Clinical
B4D will guide you through the challenges of
taking your product from preclinical through to your first in human study. We have unique expertise in early drug development and we utilize novel clinical trial designs to obtain early proof of concept in humans.
Drug Manufacturing & Quality Assurance
The B4D team provides critical project management and QA expertise from pilot scale of the API to preparation of GMP batches of drug product for clinical trials.
Regulatory Strategy
We will identify the most effective regulatory pathway based on your product and selected lead indication. We can act on your behalf to approach regulatory authorities for consultation on your product development strategy, which you will most likely be in the form of a Pre-IND or Pre-CTA meeting
Business Development & Licensing
The B4D team can work with you to develop and implement a business development and licensing strategy to support the transition of your project from discovery through preclinical to clinical and out-licensing.
Virtual Company Management
The B4D virtual management team has the necessary experience and skill set to lead you through the challenges of managing your biopharma company. We can either take over all senior management functions or “gap-fill” roles to complement your existing team.
Why Choose Us?
INTERNATIONAL EXPERIENCE
We are specialists in the international pharmaceutical and biotechnology sector with 25+ years proven expertise and success.
FLEXIBILITY
B4D has the experience, expertise and flexibility to fill the gaps in your company’s team or be your company’s entire management team.
CONSISTENT SUCCESS
Our team has a proven track record of successfully helping clients achieve their goals of product development, financing and outlicensing, on-time and on-budget.
COST EFFECTIVE
Employees with the right experience are expensive, and are generally not needed full-time at the early stages of the project. We provide access to senior experts on an as-needed basis, at a fraction of the cost of a full-time employee.
