05/02/2017

"Electronic Transer of Regulatory Information: Deadline Looms for eCTD Submission of DMFs"

Bikash Chatterjee, President & Chief Science Officer

A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that is used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. DMFs typically contain critical details required in support of the Chemistry, Manufacturing, and Controls (CMC) elements within a regulatory filing. They can also be used to provide non-CMC details such as toxicology information in support of a third-party regulatory submission. There is no regulatory requirement to file a DMF. However, detailed information required to support a regulatory filing (IND, NDA, BLA, etc.) can be included directly into the regulatory document if acceptable to all parties involved in providing the information.

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04/12/2017

"Key Considerations When Engaging a GMP Contract Service Provider"

Bikash Chatterjee, President & Chief Science Officer

Integrating a contract service provider (CSP) as part of a supply chain to bring a product to market is a critical decision that impacts business performance and carries regulatory and compliance risk.

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03/14/2017

"Examining FDA’s New Quality Agreement Guidance"

Bikash Chatterjee, President & Chief Science Officer

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02/01/2017

"FDA’s New Quality Agreement Guidance-What it Says (and What it Fails to Say)"

Bikash Chatterjee, President & Chief Science Officer

In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.

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12/01/2016

"Successfully Filing a Combination Product: Lessons Learned"

Bikash Chatterjee, President & Chief Science Officer

In the therapeutic drug landscape, combination products are one of the bright spots, with new and innovative drugs and effective delivery systems joining to bring improved medicines to a wide public. “Combo products” are composed of any blend of a drug and device. Bikash Chatterjee describes several areas that commonly impact combination product development and represent regulatory risk.

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11/04/2016

"Design Space Development- How (And When) To Get Started"

Sandra Wassink, Principal Process Engineer

In early-stage product development, the challenge of finding the optimal design space is determining what is important to achieve consistent product quality. A stepwise approach should be taken in the formulation and development process to capture characteristics or attributes that could impact product quality.

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09/28/2016

"Best Practices for Measuring System Quality for Drug Device Combination Products"

Bikash Chatterjee, President & Chief Science Officer

Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so. In this article, we will examine some common difficulties that drug companies have in measuring overall system quality, and discuss the complexities associated with investigating device returns at the end of a clinical trial.

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09/15/2016

"Avoid an FDA Warning Letter in the Laboratory Environment"

Richard Aleman, Vice President, Regulatory Compliance

The FDA’s emphasis on laboratory audits in recent years has focused on companies confirming that laboratory data is not fraudulent. With the rise in evidence that justifies the FDA’s fraudulent data concerns, especially internationally, the failure of companies to provide established historical information and ensure compliance on the validation of their analytical methods and procedures increases the risk of receiving an FDA warning letter.

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08/09/2016

"Managing QMS Disparities Between Drugs and Devices for Combination Products: A Roadmap-Part 1"

Bikash Chatterjee, President & Chief Science Officer

Combination products represent a remarkable opportunity to extend the potential patient population for biologics and improve the delivery of drug therapies.

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07/21/2016

"Managing Cold Chain Distribution Across the Global Supply Chain: Regulations and Trends"

Bikash Chatterjee, President & Chief Science Officer

Supply chains now span the globe and are increasing in complexity as organizations move away from regional business models to manufacturing and distribution on a world scale.

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