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Learn MoreCOVID-19 isn’t putting FDA out of the compliance business – Be ready for inspection alternatives
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Learn MoreSolutions for sustainable supply chains in a period of global tumult
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Learn MoreDesk-based Health Authority inspections: A risk-based approach to compliance
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Learn MoreRestricted pharmaceutical exports from India: Are you ready to mitigate risk of drug shortages?
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See Parexel's latest COVID-19 expert content
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Learn MoreCAR-T: How far have we come and where are we going?
In this episode, Doug Olson, one of the first CAR-T patients treated on a clinical trial for CLL almost 10 years ago, details his experiences with this therapy in its earliest days....
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Learn MoreReflections on Cancer Drug Development Strategies with Newly-Introduced Chinese Regulations
The global cancer drug market is set to maintain strong growth over the next decade due to factors such as environmental pollution, population aging, and poor lifestyles that leave...
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2:06Watch VideoRare Diseases: Aligning Expertise
See how Parexel are bringing together regulatory and market access experts to help companies developing rare and orphan disease products. Learn more about our Regulatory & Access Consulting Group: htt
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Parexel Regulatory & Access Overview Brochure
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Learn MoreHow the UK's HTA Agency Uses Real-World Evidence to Develop Guidance
The UK national health technology assessment (HTA) body, the National Institute for Health and Clinical Excellence (NICE), made a long-awaited announcement last week: NICE has expanded the...
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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...
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View NowInterview with Paul Bridges, Head of R&A
If regulatory and payer landscapes are so different, then why bring the two worlds together?
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2:55Watch VideoAccelerated Pathways – Alberto Grignolo
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Learn MoreEpisode 4: Accelerated Regulatory Pathways and Patient Access
In this episode, Parexel’s Mwango Kashoki, a former FDA regulator, and Richard Macaulay, who specializes in market access challenges, join Alberto Grignolo to discuss expedited regulatory pathways...
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Learn MoreFDA Inspections and Cleaning
Companies often have many questions concerning their approach to cleaning validation when it comes to preparing for an FDA Inspection. Often cleaning validation studies are extensively...
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Learn MoreCan FDA Really Do That? Understanding FDA’s Jurisdiction
On August 29, 2019 the US FDA sent a Warning Letter to Shanghai Institute of Pharmaceutical Industry (SIPI) (see the Warning Letter). The FDA charged the firm with refusing a pre-announced...
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Learn MoreRare Disease and Orphan Drug Designations - What You Need to Know
Collectively, rare diseases affect over 30 million Americans. The Orphan Drug Act (ODA), which provides the statutory basis for FDA to designate a drug or biologic agent as a therapy for a...
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Learn MoreCritical Differences Between a Form FDA 483 and Warning Letters
There are many publications and services that analyze the observations contained in Form FDA 483 documents issued to manufacturers at the close of an inspection by the U.S. Food and Drug...
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Learn MoreDoes FDA Consistently Assess Product Quality Risk and Control in Applications?
Early in 2018, the Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) published a “white paper” which contained recommendations that drug companies could consider...
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Learn MorePress announcement: Parexel unveils combined Regulatory & Access consulting organization
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Learn MoreReimagining The Global Value Dossier - Part 6
A clear value strategy is key to the success of any product attempting to enter the healthcare market; defining the right strategy should lead to the perfect positioning for your product and...
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