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.
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
Regulatory and Compliance excellence recognized for innovation across the product development lifecycle
In the US, post-market clinical studies are not required of every medical device manufacturer. However, the Food and Drug Administration (FDA) does have the authority to order post-market...
If you’re starting to explore marketing your medical device in the European Union (EU) or have a medical device that is currently CE Marked, you’re becoming familiar with the term ‘CER’ or Clinical...
On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for...
Enhancing Animal Health Compliance with Comprehensive Medical Information (MI) and Pharmacovigilance (PV) Services
Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and...
Diary of Compliance: A Year in the Life of Ensuring FDA CAPA Standards
Welcome to the Diary of Compliance, where we follow the journey of Allison Audit, the dedicated and detail-oriented Quality Assurance Manager at Acme Pharma. Over the course of a year, Allison takes...
Leveraging Offshore Excellence: Enhancing Medical Information Services Through Contact Centers in India & the Philippines
As the pharmaceutical landscape in the Japan and Asia-Pacific (JAPAC) region continues to evolve, the demand for efficient, high-quality medical information (MI) services has never been greater. Our...
What is GxP Compliance: A Detective’s Guide to Quality and Regulatory Compliance
Introduction In the brightly lit corridors, clean rooms, and warehouses of pharmaceutical and medical device industries, a mystery lurks—a puzzle shrouded in regulations, veiled in risk, and cloaked...
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...
Understanding Statistical Intervals: Part 2 - Prediction Intervals
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Formal FDA Meetings for Sponsors or Applications of PDUFA Products
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
