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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
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.
pre-clinical research
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.
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.
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.
News & Insights
December 19, 2024
WHO Issues Guidance on Antibiotic Pollution Control
WHO issues guidance to control antibiotic pollution from manufacturing, addressing environmental and global health impacts of antimicrobial resistance.
December 18, 2024
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
Explore FDA's recommendations on follow-up testing for Ames-positive drugs to support first-in-human clinical trials. Learn how to navigate FDA regulations and ensuring successful product development.
December 17, 2024
Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe
Explore the importance of market access and reimbursement strategies for medical devices and in vitro diagnostics (IVDs) in Europe. Learn how early planning and the new European HTAR can enhance the...
News & Insights
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 30, 2024
ProPharma Names Dawn Sherman Chief Executive Officer
Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.
