Southwood Research


ProPharma Group is a leading provider of comprehensive drug development, regulatory, clinical, and compliance services, dedicated to improving patient health and safety. With over 20 years of experience, they support biotech, pharmaceutical, and medical device organizations through all phases of the product lifecycle, offering tailored solutions across regulatory sciences, clinical research, pharmacovigilance, medical information, digital transformation, and quality & compliance. Their mission is to help clients bring innovative therapies to market efficiently and safely, ensuring regulatory compliance and high-quality outcomes.

Industries

biotechnology
health-care

Nr. of Employees

small (1-50)

Southwood Research

Beaconsfield, Buckinghamshire, United Kingdom, Europe


Products

regulatory sciences services

ProPharma offers support across the full lifecycle for drugs, biologics, medical devices, and diagnostics, including pre- and post-approval support for FDA, EMA, and other national competent authorities.

quality & compliance services

ProPharma brings products to market through maintenance of quality and compliance standards and records, with decades of experience in pharma consulting and regulation.

digital transformation services

Technology solutions to help life science organizations move projects through the development lifecycle quickly and efficiently, integrating science and technology.


Services

Consulting across the regulatory lifecycle, including regulatory strategy, global submissions, lifecycle management and promotional/labeling review for drugs, biologics, devices and diagnostics.

Specialised support for Biologics License Applications and other major FDA submissions, offering planning, document compilation and submission readiness review.

End-to-end clinical development services including study design, execution, global submissions and decentralized trial models for multi-phase clinical programs.

Quality systems, inspection readiness, commissioning/qualification/validation, clinical quality assurance and computer system validation services to maintain regulatory compliance.

Clinical and post-marketing pharmacovigilance covering adverse event intake, case management, signal detection, periodic safety reporting, risk management plans and global ICSR submission management.

Continuous medical information contact centre operations, adverse event and complaint intake, patient support, and medical communications including translation and content management.

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Expertise Areas

  • Regulatory sciences and global submissions
  • Clinical trial management and decentralized trials
  • Pharmacovigilance and drug safety
  • Medical information and patient support operations
  • Show More (9)

Key Technologies

  • AI-driven medical information automation
  • Generative AI for medical information workflows
  • 24/7 contact centre platforms for medical information
  • Decentralized clinical trial platforms and remote monitoring tools
  • Show More (7)

News & Updates

Participation in a premier event in Hyderabad, India, on August 22, 2025, focusing on drug safety.

A webinar exploring inspection pitfalls and how to maintain readiness, scheduled for July 29, 2025.

Insights into FDA expectations for ANDA submissions, led by former FDA reviewer Marshall Florence, on July 22, 2025.

Key responsibilities for market authorization in the EEA/UK, scheduled for July 10, 2025.

ProPharma wins Silver for AI innovation in Medical Information at ECCCSA, January 31, 2025.

Awarded for regulatory and compliance innovation, October 9, 2024.

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