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Consulting on Preclinical Development & Regulatory Expectations

Our consultants cover all aspects of toxicology, pharmacology and pharmacokinetics/ metabolism IND enabling programs (505(b)(1 & 2) for small molecules and biologicals, including medical device combination and over the counter products

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PharmaFacts can provide one consultant or a collaborative team that expands or contracts as needed.

Bridge the Gaps, save time and money. Strategic guidance to ensure you meet regulatory requirements for your IND-enabling programs and non-clinical support for market approval

Based on preliminary discussions, we help you select the right people from our diverse network of independent experts.
Our Expertise

All Your Preclinical Challenges, Solved

Our Services

FULL PRECLINICAL SAFETY CONSULTING PROGRAMS

PharmaFacts’ preclinical safety consulting optimizes processes and procedures in preclinical operations. We help you get it right. More…

CRO SELECTION AND MANAGEMENT

PharmaFacts extensive experience and long-standing relationships with contract research organizations (CROs) allows us to help you select the CRO best suited for your needs. More…

CARDIAC RISK-BENEFIT EVALUATIONS

PharmaFacts’ cardiac risk-benefit assessment expertise is highly regarded in the industry.  We help you put together the right studies that address cardiovascular safety issues. More…

QUALITY MANAGEMENT SYSTEMS CONTROL

PharmaFacts understands how to implement quality management in stages over the course of the drug development process according to what is appropriate for your biotech company. More…

PRECLINICAL STUDY DESIGN

PharmaFacts provides highly trained scientists to take your preclinical drug development from discovery to IND success—and every step in between. We step in when you need us most. More…

REGULATORY SUPPORT

PharmaFacts understands regulatory expectations and can help you stage your preclinical studies in parallel with your clinical program to prepare you to make impactful decisions. More…