Quality & compliance
-
Learn MoreHow market exclusivities can affect your development program
-
2:08Watch VideoParexel on the pulse
Parexel regulatory expert, Mark Birse, gives an update on BREXIT.
-
Learn MoreThe Evolving Cell and Gene Therapy (CGT) Sector in China
-
Learn MoreFive points to remember if FDA issues a Form 483
-
View NowCase Study Achieving Product Endorsement after a FDA Warning Letter
-
View Now
Compliance Consulting Services Brochure for Law Firms
-
View NowHow to interact virtually with health authorities
-
Learn MoreGxP On-Site Inspections are Restarting: Preparing for inspections under the “new normal”
As global regulatory agencies are preparing to return to on-site inspections1, industry needs to be ready. With the continued threat of COVID-19, the way inspections will be performed and hosted...
-
View Now
Risk Mitigation and Compliance Consulting Brochure for BioPharma Companies
-
Learn MoreFDA Expectations for Responding to Employees in Pharmaceutical Manufacturing Infected with COVID-19
Global manufacturers and regulators are facing new challenges during the SARS-CoV-2 pandemic to maintain supply chains, and avoid shortages, of drugs, biologics and medical devices. Numerous...
-
Learn MoreNavigating new steps in how FDA is managing COVID-19 Products
-
Learn MoreBiosimilars in the time of COVID-19 and beyond
Introduction The recent COVID-19 pandemic has triggered a race for pharmaceutical companies to repurpose their commercialized drugs approved for other clinical indications to treat patients...
-
Learn MoreConsiderations for protecting your business and employees from COVID-19
This assessment highlights some planning considerations to help you maintain business operations, while protecting the safety of employees and customers during this pandemic.
-
Learn MoreUnderstanding the COVID-19 regulatory procedures the FDA is using
A diagram that shows various procedural steps when interacting with the FDA through CTAP.
-
Learn MoreRestricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?
-
Learn MoreUnderstanding Department of Justice Enforcement Policies relating to FDA-Regulated Products
At the recent 2019 Enforcement, Litigation and Compliance Conference hosted by the Food and Drug Law Institute (see here), Deputy Assistant Attorney General David Morrell delivered the...
-
Learn MoreWhat Influences the Compliance Culture at FDA?
The Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) is a large organization. It has hundreds of personnel who are...
-
Learn MoreFDA & Nitrosamine Impurities – The Proverb of the King with Long Arms
If the dictionary is to be believed, the expression that kings have long arms was first listed as a proverb in 1539 (see here). Over time it has developed into the commonly recognized idea...
-
Learn MoreAs PIC/S expansion continues, what does this mean for manufacturers seeking to join?
Over the last few years the expansion of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) has continued at pace, with more Good Manufacturing Practice (GMP) Inspectorates joining,...
-
Learn MoreIt’s Not Just Manufacturing – Drug Development Presents Corporate Compliance Risks Too
In a prior blog post, I wrote about the issue of whether corporate boards of directors could be confronted with the issue of whether they could be held liable for not implementing a...
-
Loading More...
