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.
Navigating FDA Layoffs: OPDP Cuts and the Rising Stakes of Ad Compliance
The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion
The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food and Drug Administration (FDA), is responsible for ensuring prescription drug advertising and...
On April 26, 2023 the Commission adopted a proposal for a new Directive and a new Regulation which revise and replace the existing general pharmaceutical legislation under the following...
The Care and Feeding of FDA PMAs: Mastering Premarket Approval
Congratulations, FDA has approved your PMA! Now what? Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's...
Navigating EU GMP Compliance: A Consultant's Guide to Smooth Sailing
Hello, fellow pharma enthusiasts! In the fast-paced world of pharmaceuticals, ensuring Good Manufacturing Practice (GMP) compliance is essential to maintaining product quality and safety. The...
Navigating the Regulatory Maze: Clinical Data for Medical Device Approval
In the world of medical devices, particularly those categorized as moderate to high-risk, clinical data is a critical component of the regulatory approval process. This data, presented to regulatory...
Building Clinical Quality Assurance: Unlock the Full Potential of Your Clinical Development
In the dynamic world of pharmaceuticals and biotechnology, small Sponsor companies are often the unsung heroes driving innovative therapies through the complex journey from concept to clinic. With...
Staying GMP Compliant: A Consultant's Guide to Compliance Bliss
Hello, dear readers and fellow compliance enthusiasts! Welcome to our journey through the labyrinth of Good Manufacturing Practices (GMP) compliance. As a consulting company that provides audit...
Ensuring Quality in Clinical-Phase Drug Manufacturing: A Comprehensive Guide
Importance of Quality Assurance in Clinical-Phase Drug Manufacturing Quality Assurance (QA) is a critical function in the pharmaceutical industry, ensuring that every aspect of drug manufacturing...
How a Strong Regulatory Strategy Supports Your Product’s Success
One of the big questions pharmaceutical, biotech and medical device companies often ask, is: “When is the optimal time to seek strategic regulatory consulting assistance?”. Traditionally, the need...
Risks to Consider when Implementing AI Technology in Medical Information
AI is a highly praised tool to implement across industries and service lines and Medical Information (MI) is no exception. In Medical Information, AI is embedded in a workflow for patients and...