preclinical research

Advisory support to determine starting dose, conduct IND-enabling studies and development of required evidence

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Trusted Regulatory and Product Development Expertise

Prior to being used in a human, researchers perform testing in controlled laboratory settings. Results during this phase provide researchers with important information about the potential uses in humans and attempts to reduce risk of harm in people. While it is almost never possible to eliminate risk entirely, risk management evaluation can be performed. ProPharma’s expertise spans across the following Preclinical Research competencies:

  • Translational/Preclinical Work
  • Lead Optimization
  • IND/CTA Enabling Studies
  • Program Design & Planning
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Preclinical Research Services

ProPharma provides advisory support to determine starting dose, conduct IND-enabling studies and development of required evidence. Our robust team of experts will provide the guidance you and your team needs to ensure good laboratory practices (GLP) and will tailor services based on your specific needs.

Translational / Preclinical Work

Our translational/ preclinical service offerings help move your from discovery to IND prep and submission with confidence and ease. We provide services that meet global requirements across IND-enabling and NDA-enabling that meet global regulatory requirements for molecules of all sizes.

Our solutions include:

  • Manufacture of drug substance (DS)/active pharmaceutical ingredient (API)
  • Dosage design
  • Analytical and bioanalytical methods development and validation
  • Pharmacokinetics
  • Toxicology, both safety and genetic toxicology
  • Good manufacturing practice (GMP).

We partner with you to ensure a frictionless transition to first-in-human trials.

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Lead Optimization

As the last step in the preclinical development process, lead optimization is a crucial step for a drug candidate to move into future clinical development. We help you move through the process rapidly and with expert guidance to ensure the most promising compounds are optimized, improving the success probability for your drug candidates. Move confidently from lead optimization to IND study with our comprehensive suite of services and customizable solutions.

IND/CTA Enabling Studies

An investigational new drug (IND) and clinical trial application (CTA) must be completed in both the USA and Europe to progress a compound to first-in-human clinical trials. Successful completion of IND/CTA enabling studies provides detailed analyses for health authority review and allows for formal application submission(s) with the FDA and/or EMA. Health authority requirements vary by region, so it is critical to understand the specific needs of each before IND/CTA enabling studies are designed and planned. Gaining a full understanding of the requirements of each health authority will enable optimal resource allocation and spend.

ProPharma's proven track record with designing and performing IND/CTA preclinical studies enables your team to achieve speed and efficiency with submissions for first-in-human clinical trials.


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Program Design & Planning

A well researched strategic roadmap is essential when beginning a new drug development program. This process will enable efficiency, reduce timelines and costs and can potentially increase the probability of success for the program. ProPharma’s diverse team of experts can assist you and your team across target product profile (TPP), regulatory, non-clinical and clinical, manufacturing, and commercial plans. Ensuring all of these components are considered and incorporated into a seamless strategic document plan is the first step in moving towards achieving your program’s objectives.


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News & Insights

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News & Insights

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Strategic Leadership Appointments to Propel Global Growth RALEIGH, April 10, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

January 24, 2024

ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...

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January 4, 2024

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Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

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October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

August 15, 2023

ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...

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EU Regulatory Sciences EU Pharmaceutical Legislation Reform: Where Are We Now?

March 26, 2024

EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

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LPPV PSMF QPPV Pharmacovigilance Achieving Success with Regulatory Intelligence in Pharmacovigilance

March 25, 2024

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What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...

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June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

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Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

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Complex Needs Require Custom Solutions

ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.