10/02/2017

"Cover Story, A Breakthrough for Industry and Patients, a Change in Family Dynamics for Patients"

Scott Fotheringham, PhD,

Includes commentary and interview with Mihaela Simianu, PhD

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09/26/2017

"How Should I Respond To This FDA Warning Letter? (and Other Compliance Questions Answered)"

Richard Aleman, Vice President, Regulatory Compliance

Richard Aleman, VP of regulatory compliance at Pharmatech Associates, has an insider’s view on global regulatory issues having spent almost three decades at the FDA, specializing in biopharmaceuticals, drugs, and medical devices. In a guest column published in Pharmaceutical Online, talks about warning letter responses and remediation and other important regulatory issues. Some of the most common questions about compliance concern dealing with the FDA 483 list of inspection observations, warning letters, and consent decrees following FDA regulatory action.

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09/06/2017

"Preparing for the New European Medical Device Regulation"

Bikash Chatterjee, President & Chief Science Officer

The European parliament published new regulations for medical devices (MDR) and in-vitro diagnoistics (IVDR) on May 5, 2017, capping almost eight years of negotiations between the European Union Council, Parliament, and Commission. Each regulation was published in the European Official Journal on May 25, 2017.

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08/30/2017

"Process Design & Risk Management – A Proactive Approach"

Sandra Wassink, Principal Process Engineer

The latest article by Sandra Wassink of Pharmatech Associates in Pharmaceutical Online discusses a strategy to implement risk management during the process design stage of process validation for quality product, and to use as a proactive means of addressing quality controls during the subsequent stages of development. Managing risk from the outset helps prioritize what efforts need to be made during process design.

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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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