discovery & development
Drug discovery specialists for all phases of your product lifecycle.
Accelerate Drug Development
Delivering new drugs and therapies to market is a complex process which includes both discovery (target identification and validation, hit identification, lead generation & optimization, identification of a viable candidate for future & further development) and development (optimization of chemical synthesis and formulation, toxicological studies, clinical trials, and regulatory approval) stages. ProPharma’s expertise spans across the following Discovery and Development competencies:
- Technology Transformation
- Research Platforms
- Target Identification
- Lead Validation
- Scientific Advisory and Regulatory
Discovery & Development Services
ProPharma’s Discovery and Development experienced consulting services help you avoid potential obstacles, navigate the drug development process and expedite your efforts to ensure the best possible outcome for your assets.
Discovery & Development
Technology Transformation
Now, more than ever, companies are transferring products and processes from one site to another, often facing limitations on time, resources, and regulatory expectations. Transfers can be complicated, and many companies don’t have a technology transfer plan, standard operating procedures (SOPs) or guidelines in place to effectively conduct the transfer.
Our cross-functional team of consultants have proven success in managing product and process transfers for clients around the world.
Manageable Milestones for Successful Technology Transfers
ProPharma’s proprietary Gated Technology Transfer disciplines are customizable to meet your specific production and technology demands.
Our approach provides a robust process framework to consistently transfer technologies from development to production, or from site to site in a compliant and efficient manner.
We collaborate with you to finalize the milestones (or gates) so that your organization understands the approach and can effectively make decisions throughout the process. We have successfully completed more than 175 product transfers using our Gated Technology Transfer approach. Clients credit this successful methodology in helping them navigate the complexities of the technology transfer process while realizing efficiencies along the way.
Research Platforms
ProPharma understands that you have an important job in getting your product to the clinic and eventually to patients. Your technology should enable you to do this more quickly and efficiently. Let our team of experts develop and deliver tailored roadmaps to help you hit your milestones.
Key Platforms
There is a range of Research systems that can store your data and provide analytics to help you make data-driven decisions about the outcomes of your study. These systems support the life cycle of your product and are comprised of an array of technologies including:
- Electronic Lab Notebooks (ELNs)
- Research Data/Laboratory Data Management Systems (LIMS)
- Document Management Systems
- Imaging Platforms
- Data Warehouse and Analytics
- Data Visualization and Reporting
- Bioinformatics & Data Science platforms
- Machine Learning/Artificial Intelligence Platforms (ML/AI)
Target & Lead Selection
Propharma’s team of leading regulatory experts utilize a science-first approach to understanding your product, combined with first-hand insights of regulatory expectations to augment target-to-disease relation. Expert review of the literature, in vitro, ex vivo, in silico, and early non-Good Laboratory Practice (GLP) exploratory in vivo assessments will enable the selection of drug candidates with an acceptable safety profile and provide the opportunity to reduce attrition and increase the success of drug development.
Expert Discovery/Exploratory Toxicology Assistance
ProPharma’s experts understand regulators’ interest in biomarker and mechanistic data and the ability of these data to define organs’ and cells’ sensitivity to therapeutic agents. We can assist with the design, evaluation, and optimization of investigative toxicity and exploratory/discovery studies for candidate therapeutics early in the drug discovery process. In addition to a Sponsor’s own data, we utilize publicly available information to identify potentially supportive data.
ProPharma can help establish the relevance of in vitro and animal data to humans in support of the initiation of clinical testing. Our expertise in typical early discovery assessments includes, but is not limited to:
- In vitro and in vivo models for the mechanism of action and efficacy assessments
- CEREP/Kinase panels to flag off-target activities of compounds
- Cell culture, tissue slice, 3D tissues models, and Organs on a Chip
- In vitro human ether-a-go-go-related gene (hERG) and cardiovascular studies
- In vivo cardiovascular, pulmonary, central nervous system (CNS), gastrointestinal, and renal assessments
- In vitro metabolism and drug interaction studies
- In vivo pharmacokinetic (PK) studies (various species and routes of administration)
- Quantitative structure-activity relationship (QSAR) assessments for genotoxic potential
- In vitro and in vivo genotoxicity tests
Scientific Advisory and Regulatory
ProPharma provides high-value advisory services through its worldwide base of top-tier expert consultants, who support the full product development life cycle, from initial concept to marketing authorization. Advisory services include product development and regulatory strategy, development program planning and management, and expert scientific and technical advice.
Expert Advisory Services
ProPharma’s worldwide team is comprised of highly knowledgeable experts with extensive experience preparing and submitting applications, including:
- Investigational New Drug (IND) applications
- Abbreviated New Drug Applications (ANDAs)
- New Drug Applications (NDAs)
- Biologics License Applications (BLAs)
- Premarket Approval (PMAs)
- 510(k) (Premarket Notification) and de novo submissions
- Special designations
ProPharma’s team of experts can act as the Regulatory Representative for the FDA and international regulatory bodies on behalf of a client and can take on leadership roles such as membership on Scientific Advisory Boards or working on a part-time basis as an interim executive (e.g., Chief Medical Officer, Head of CMC, and Head of Regulatory Affairs).
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.
News & Insights
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...
March 25, 2024
Understanding PIPL: Compliance and Implementation Challenges
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
March 25, 2024
Achieving Success with Regulatory Intelligence in Pharmacovigilance
What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...
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...
January 4, 2024
Innovation and the Black Swan Prodigy Whitepaper
Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...
January 4, 2024
ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry
Whitepaper published alongside today's announcement details $5M+ investment and up to 50% improvement in speed, quality, and cost with new AI-enhanced solutions. RALEIGH, NC, January 4, 2023 –...
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,...
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...
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...
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...
August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...
News & Insights
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...
January 4, 2024
ProPharma Unveils Prodigy: Groundbreaking Technology-Enabled Consulting Platform to Revolutionize Life Science Consulting Industry
Whitepaper published alongside today's announcement details $5M+ investment and up to 50% improvement in speed, quality, and cost with new AI-enhanced solutions. RALEIGH, NC, January 4, 2023 –...
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,...
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...
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...
March 25, 2024
Understanding PIPL: Compliance and Implementation Challenges
What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...
March 25, 2024
Achieving Success with Regulatory Intelligence in Pharmacovigilance
What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...