05/19/2020

"Navigating The FDA’s Emergency Use Authorization Process"

Bikash Chatterjee, Chief Operating & Science Officer

In an article in Outsourced Pharma, Bikash Chatterjee writes that understanding the FDA’s expectations will allow drug sponsors to make the most of available data derived during the emergency use authorization (EUA) and position them for a smoother regulatory process.

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04/24/2020

"Ensuring Quality In Ventilator Production Scale-Up For COVID-19"

Bikash Chatterjee, Chief Operating & Science Officer

Manufacturers around the world are scrambling to scale up ventilator manufacturing to meet the worldwide needs of COVID-19, and we find ourselves in uncharted territory.

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04/21/2020

"Guest Editorial: Consulting Firms Can Fill In Missing Pieces"

Stephanie Gaulding, Director, Regulator Compliance

Consulting firms routinely find themselves in a highly valued position during a crisis. Their very business models demonstrate an ability to maintain strategic project performance with distributed teams. Their focus can quickly shift to best meet the evolving needs of a client as they recognize and face the challenges of new realities.

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04/03/2020

"Pharma 4.0 Supply Chain Security and Data Integrity for Advanced Therapies"

Bikash Chatterjee, Chief Operating & Science Officer

Key points to consider in a Pharma 4.0 supply chain, for organisations looking to bring advanced therapies to market.

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03/04/2020

"Business Continuity & the Coronavirus: Are Your Pharma Operations at Risk?”"

Bikash Chatterjee, Chief Science & Operations Officer

Bikash Chatterjee proffers a framework for pandemic preparedness to help organizations ensure business continuity, build high-level resilience in all departmental services and sites, and adapt to operational risks.

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02/04/2020

"Evaluating New FDA Draft Guidance-Qualification Process for Drug Development Tools"

Bikash Chatterjee, Chief Operating and Science Officer

Bikash Chatterjee writes that the benefits of FDA’s new qualification process guidance could be profound, both in shortening the development timeline and accelerating the review process.

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01/07/2020

"Meeting Clinical Trial Data Requirements in Asian Markets"

Caitlin Bancroft, Regulatory Affairs Associate

Pharmatech’s Caitlin Bancroft discusses strategies for drug sponsors looking to launch products that are ready for Asia.

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11/01/2019

"Understanding the FDA’s Knowledge-Aided Assessment and Structured Application (KASA) Framework"

Bikash Chatterjee, President & Chief Science Officer

KASA represents an ambitious step forward for the FDA in standardizing and increasing the efficiency of the drug review process. Bikash Chatterjee writes that the challenge will be to set up risk evaluation standards that serve the spectrum of current and future drug therapy programs and leverage industry’s experience in creating and managing these systems.

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10/25/2019

"Hurry Up and Wait: Brexit from a Regulatory Point of View Part 2"

Lynn Hansen, Director, Regulatory Affairs

Lynn Hansen talks about strategic contingency plans, in the form of numerous government guidance/instructions developed for “a Brexit deal” or “no Brexit deal.” When the UK’s Medicines and Healthcare Regulatory Agency (MHRA) becomes the UK regulatory authority once again, it may end up obtaining a seat on International Council on Harmonization (ICH).

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10/24/2019

"Hurry Up and Wait: Brexit from a Regulatory Point of View"

Lynn Hansen, Director, Regulatory Compliance

Lynn Hansen points out the challenges that stem from Brexit for regulators guiding the transition for pharmaceutical, medical device, biotech, and veterinary companies, and the resources in place to ensure that the supply chain of valuable products for many patient populations can be maintained.

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