Regulatory Sciences
Three Steps Towards Complying with Nitrosamine Regulations
All Marketing Authorization Holders (MAH) of medicines for human use are facing what might feel for many, as a new requirement: review their drug products on the possible presence of nitrosamines....
FSP Solutions
5 Ways a Functional Service Provider Can Support Your Clinical Development Project
When pharmaceutical companies launch a clinical trial or reach a certain phase of Clinical Development, with only the support of their in-house employees, the additional workload often becomes too...
Clinical Research Solutions
Life Sciences Data Analytics: The Importance of Big Data
Big data is hitting us from all angles, and life science industries are not being left out. Why? Your life depends on it, literally. Life sciences generate lots of large and complex data every single...
Clinical Research Solutions
6 Compliance Tips to get FDA Approval for Your Pharmaceutical Project
FDA Approval Process Overview The Food and Drug Administration (FDA), as part of the United States (US) Department of Health and Human Services, is the regulatory agency responsible for the review,...
Clinical Research Solutions
Gene and Cellular Therapies: Five Keys to Regulatory Success
We are living through a medical revolution. Advances in gene therapy, cell‑based therapies and tissue engineering offer real hope for patients with a range of debilitating diseases. The FDA, EMA and...
Deviations: Beyond the Basics
There are plenty of guidelines and instructions on implementing a deviation system in a pharmaceutical/medical device company. However, there is a big difference between theory and practice when it...
Why the FDA Should Never Be Your First Inspection
You can expect several FDA audits throughout your drug development program The Agency’s goal is to protect the public from unsafe products, and one of the best ways to accomplish that goal is by...
Clinical Research Solutions
FDA's Top 483 Observations for 2018: A Reflection of Industry’s Compliance
At the beginning of each federal fiscal year, the US FDA posts the previous year's Form 483 observation metrics issued by each product center. Inspections ending between 10/1/2017 and 9/30/2018, for...
Meet the Expert: Mary Speckin
ProPharma Group has launched a "Meet the Expert" series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...
Clinical Research Solutions
Assumed Brexit & Batch Control Testing Site In the UK
The currently scheduled transition date in the Brexit process, 30 March 2019, is coming very close. In light of this, the European Commission (EC) published on 25 February 2019 a notice on the...
Clinical Research Solutions
Year in Review: Taking a Look at Pharma's Top News Stories & Events from 2018
From FDA's approval of the first cannabis-based product in the U.S., to the classification of two Apple Watch apps and changes in the Agency's submission requirements related to Sponsor meetings,...
Innocent Until Proven Guilty: Hypothesis Test
Each of us makes important decisions that shape our lives, every day. We try to make the best decisions possible and yet, as the adage goes "all predictions of the future are wrong, some are just...
Clinical Research Solutions
Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations
Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...
Clinical Research Solutions
Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
Regulatory Sciences
CBER Provides Sponsors with Policies and Procedures Regarding INTERACT Meetings
On Monday, October 1, FDA’s Center for Biologics Evaluation and Research (CBER) issued a document outlining the policies and procedures for scheduling and conducting INitial Targeted Engagement for...
Good Review Management Principles & Practices, Part One: Fundamental Values
On Tuesday, September 25th, the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics...