Clinical Research Solutions

ProPharma's validation professionals leverage the latest risk-based Computer System Validation (CSV) and Computer Software Assurance (CSA) techniques to ensure that our clients' systems are ready for inspections from the FDA, EMA, MHRA, and other regulatory agencies. Our consultants have extensive experien...

Our auditors have real world experience supporting regulatory inspections and preparing companies for pre-approval inspections. Our team of specialists includes former regulatory agency inspectors and qualified auditors who are proficient in conducting mock inspections, internal audits, vendor and s...

Project resource management includes forecasting the need to hire and/or outsource some tasks. When projects are high-value and require strategic decisions, in-house resources may be insufficient. Similarly, administrative action items are better left to contract workers so as to not overburden your staff....

ProPharma’s Drug Development Team is a multidisciplinary team of scientists, engineers, nonclinical, clinical, and quality experts with the experience to guide drug through development.

Our unique combination of expertise in US and EU Regulatory Affairs, CMC, and GMP allows us to connect...

Navigating both general and country-specific regulations and requirements to supply medicinal products to the European markets can be a complex challenge for Marketing Authorization Holders (MAH). ProPharma holds both EU and UK MIA licenses which allows us to help clients overcome the complexities of su...

From early-stage development through commercial support, our experts provide critical GxP-based consulting services. We partner with clients to successfully execute projects throughout the product lifecycle to maintain quality & compliance with applicable regulations and industry standards. qq...

From early-stage development to post-approval, we partner with pharmaceutical, biotechnology, and medical device clients to overcome regulatory hurdles. Using science as the driver for success, we help our clients achieve positive regulatory outcomes with the Food and Drug Administration (FDA), Europea...

RCO Vs CRO: Drug and Device Development Outsourcing 2.0
Traditional CRO push a full-service, "cookie-cutter" agenda, offering little compromise for the small Sponsor; ProPharma’s Research Consulting Organization RCO model leads with strategy to help de-risk programs and create tailored solutions to maximize probability of success.

ProPharma has transformed its organizational structure and solutions to put its clients at the very center. We offer a suite of bespoke consulting solutions across service lines and functional areas of expertise to span the full product life cycle. ProPharma embraces partnerships to reduce delays and drive consistency with dedicated and experienced strategists and program managers for end-to-end oversight.