Dark Horse Consulting

Focused Excellence in Cell & Gene therapy

Based on pharmaceutical industry best practices

Common Services Offered

PROJECT PLANNING AND MANAGEMENT:

Program oversight, from systemic tactical project management to strategic portfolio stage-gating and development

PROCESS DEVELOPMENT PLANNING:

Process and analytical method development, from research through Phase I-III and pre-commercial stages

PRODUCT DEVELOPMENT PLANNING:

Data and trend analysis of your manufacturing to date, enabling future needs, capacity and budget modeling


FAILURE ANALYSIS:

Help! My process suddenly stopped working! Root Cause Analysis and Corrective And Preventative Action (CAPA) will put you back on track and keep you there

MANUFACTURING EVALUATION:

cGMP manufacturing oversight, tech transfer and support. Identification and contracting of appropriate domestic and international CMOs

QUALITY PROGRAM STRATEGY:

Development and implementation of stage-appropriate documentation and quality systems


STAY AHEAD OF THE REGULATORY CURVE:

Planning, authoring and submitting of worldwidefilings

GOVERNMENTAL AFFAIRS:

Become well connected to a focussed selection of individuals versed in persuasive interaction with lawmakers and federal agencies

SECURE YOUR FUNDING:

Pre-meeting diligence, introduction to and negotiation with motivated investors and corporate partners

What Social Media Says

What Our Customers Say

Dark Horse Consulting has supplied invaluable support to the Stanford University Stroke Disease Team. They have coordinated functions as diverse as pilot and outsourced cGMP manufacturing, analytical development, quality systems and regulatory affairs. Further, their subject matter expertise has greatly enhanced the Neurosurgery Department’s interactions with the CIRM and the FDA.

Gary K. Steinberg, M.D., Ph.D.
Bernard and Ronni Lacroute-William Randolph Hearst Professor of Neurosurgery and the Neurosciences - Chairman, Department of Neurosurgery - Stanford University School of Medicine

In my opinion Dark Horse Consulting is anything but the ‘dark horse’ team to select when choosing a consultancy to accomplish what you need and more. Given their depth of experience, expertise and connections this is a team you’d predict to win – a team you want adding value to your efforts. Retaining this firm is not for the faint of heart or weak of expectations. This is a team which will pull no punches, recognize no limitations, raise the bar higher than anyone internally has dared, compete harder, and accomplish more. Dark Horse Consulting’s founder, Anthony Davies, is a renaissance man of biologics development who has set the tone for his firm as one which will act with respectful honesty (even when it’s not the news a client wants to hear), transparent integrity, and rigorous compliance with the highest standards and yet perform comfortably with the tough trade-offs and practical parameters often facing biotech companies. My only hesitancy in hiring Dark Horse Consulting would be if I wasn’t prepared to fully commit to getting things done and done the right way.

Lee Buckler
President & CEO, Director at RepliCel Life Sciences Inc.

It has been a pleasure collaborating with Dark Horse Consulting. They provide deep expertise and the ability to clarify and focus federal regulators’ attention on critical issues. Such contributions are invaluable in moving complex biologicals smoothly along the path to approval.

Judi Weissinger, PhD
Formerly Assistant Director, Offices of Drug Evaluation I and II, CDER, FDA and formerly Assistant Director, Office of Drug Evaluation I, CDB

Contact Us

Anthony Davies, Chairman

Dark Horse Consulting, Inc.

anthony@darkhorseconsulting.us

408-326 0303 Ext. 101

Standard Terms & Conditions