Insights
News
Thought Leadership
ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.
Recent Articles:
FDA Releases Final ICH M13A Guidance Document
On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”. This guideline provides recommendations for conducting bioequivalence (BE) studies during development and post-approval phases for...
The Evolving Landscape of Quality Management Systems in the Life Sciences Industry
In the decades since the FDA first introduced Good Manufacturing Practice (GMP) regulations, the drug and device industry has undergone significant transformation. While the core principles of GMP—safety, efficacy, and quality—remain foundational, the way manufacturers achieve these goals has...
Pre-Approval Inspection (PAI) Readiness is Easy, Right?
Facing a pending filing and subsequent PAI can feel overwhelming, no matter if you are a young firm or an established company. You're balancing the excitement of bringing a new product to market with the reality of limited resources. For many companies, regardless of size and tenure, the...
Resources
As the world’s largest RCO, ProPharma is committed to delivering dynamic research and perspectives crafted by world-class subject matter experts. ProPharma provides valuable insights to its clients to enable thoughtful decision making, as well as informed resource & investment allocation.
From Concept to Certification: Building a QMS in the MedTech Space
Learn how ProPharma helped SMi Systems establish a robust Quality Management System (QMS) while building their company from the ground up. This case study details their journey to ISO 13485:2016 certification, overcoming challenges in the competitive medical device market, and achieving rapid...
Good Science Presented Well Generates Regulatory Approvals
Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest and best path to approval. Obtaining marketing approval for a pharmaceutical, biotech, or medical...
Streamlining Adverse Event Reporting in JAPAC
A ProPharma Medical Information (MI) Lead working alongside a pharmaceutical company successfully streamlined the adverse event (AE) reporting process in the JAPAC region, particularly addressing issues in China where a 100% rejection rate by a local safety vendor hindered timely reporting. The MI...
Press Room
ProPharma is at the forefront of the life sciences industry and continues to innovate and elevate its position as the world’s largest RCO. Stay up to date on ProPharma’s latest news and most recent announcements.
Recent Press Articles:
ProPharma Appoints Brian Tuttle as Chief Financial Officer
Seasoned Life Sciences Executive to Spearhead Financial Strategy and Drive Accelerated Growth. Raleigh, NC, October 21, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment...
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
Regulatory and Compliance excellence recognized for innovation across the product development lifecycle RALEIGH, NC, October 9, 2024: ProPharma, a leading global provider of regulatory, clinical, and compliance services for the life sciences industry, is pleased to announce it has won the...
ProPharma Names Dawn Sherman Chief Executive Officer
Veteran Life Sciences and Biopharmaceutical Industry Executive Previously Served as ProPharma CEO Raleigh, NC, September 26, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey Investment...
Awards
With over 20 years of proven success, ProPharma continues to be acknowledged within the life sciences industry for providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma proudly shares its recognition and achievements as its team works to improve the health and safety of patients.
Recent Awards:
ProPharma Appoints Brian Tuttle as Chief Financial Officer
Seasoned Life Sciences Executive to Spearhead Financial Strategy and Drive Accelerated Growth. Raleigh, NC, October 21, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry and a portfolio company of Odyssey Investment...
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
Regulatory and Compliance excellence recognized for innovation across the product development lifecycle RALEIGH, NC, October 9, 2024: ProPharma, a leading global provider of regulatory, clinical, and compliance services for the life sciences industry, is pleased to announce it has won the...
ProPharma Names Dawn Sherman Chief Executive Officer
Veteran Life Sciences and Biopharmaceutical Industry Executive Previously Served as ProPharma CEO Raleigh, NC, September 26, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey Investment...
Events
ProPharma is committed to engaging with both existing and prospective clients at the right time and in the right place. Speak with a member of the team at one of these upcoming events.
Inspiring the Future of Drug Development
We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.