Quality & compliance
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How market exclusivities can affect your development program
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2:08
Parexel on the pulse
Parexel regulatory expert, Mark Birse, gives an update on BREXIT.
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The Evolving Cell and Gene Therapy (CGT) Sector in China
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Five points to remember if FDA issues a Form 483
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Case Study Achieving Product Endorsement after a FDA Warning Letter
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Compliance Consulting Services Brochure for Law Firms
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How to interact virtually with health authorities
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GxP 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...
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Risk Mitigation and Compliance Consulting Brochure for BioPharma Companies
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FDA 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...
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Navigating new steps in how FDA is managing COVID-19 Products
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Biosimilars 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...
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Considerations 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.
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Understanding the COVID-19 regulatory procedures the FDA is using
A diagram that shows various procedural steps when interacting with the FDA through CTAP.
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Restricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?
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Understanding 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...
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What 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...
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FDA & 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...
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As 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,...
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It’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...
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