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Quality & Compliance
Compliance Consulting Services Brochure for Law Firms

Compliance Consulting Services Brochure for Law Firms

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Case Study Achieving Product Endorsement after a FDA Warning Letter
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Parexel Webinar Regulatory Inspections Post COVID

Parexel expert, Mark Birse, a former MHRA regulator, addresses how the pandemic changed new inspection practices and remote desktop facility assessments. He shares his opinions on the long-term impact

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Impending avalanche of regulatory compliance activity: Are you prepared?

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How market exclusivities can affect your development program

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Parexel on the pulse

Parexel regulatory expert, Mark Birse, gives an update on BREXIT.

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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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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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