"FDA Focus Areas of Regulatory Science (FARS): Five Trends to Watch"

Bikash Chatterjee, Chief Executive Officer

FDA’s 2021 Focus Areas of Regulatory Science capture an agency that is looking to provide meaningful regulatory insight on new and emerging approaches to drug development and governance.

"Essential Elements of a Data Management Plan for Outsourced Drug Development"

Bikash Chatterjee, Chief Executive Officer

The world’s need for COVID-19 vaccines has rewritten the rules of drug development. A data management plan is crucial to the ability to gather and use data from across the value chain. As drug sponsors extend the development and manufacturing enterprise to include CDMO partners, sharing access to relevant data affects time to market and simplifies program decision-making.

"FDA Steps Up Support for Advanced Manufacturing Technologies"

Bikash Chatterjee, Chief Executive Officer

Bikash Chatterjee points out that the FDA’s commitment to innovation goes beyond providing guidance alone. The agency supports the adoption of advanced manufacturing technologies (AMTs) that can improve drug quality, address medicine shortages, and speed time-to-market.

"ASQ Quality’s Impact On the Pandemics Global Response"

ASQ Technical Community, Stephanie Gaulding

ASQ Technical Community chairs including, Stephanie Gaulding, Director of Compliance at Pharmatech Associates contributed to this introduction on the role quality played in the COVID-19 vaccination process. This piece highlights how quality principles are foundational for industries integral to each stage of the COVID-19 response (vaccine development and approval, distribution, and administration).

"Certifying Pharmaceutical Exports: A Roadmap To EMA’s Certificate of Medicinal Product"

Michael Cooper, Clinical & Regulatory Affairs Program Manager

In Part 2 of a two-part series, Mike Cooper of Pharmatech Associates reviews how a product approval within the European Economic Area (EEA) can be leveraged to support registration in new markets through the Certificate of Medicinal Product (CMP).

"Best Practices for Designing and Building a Pharmaceutical Manufacturing Facility"

Allison A. Cacciatore, Executive Director Facilities Design and Engineering

For drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial.

"Certifying Pharmaceutical Exports: An Introduction To FDA’s Certificate Of Pharmaceutical Product"

Michael Cooper, Clinical & Regulatory Affairs Program Manager

When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. In Part 1 of a two-part article, Mike Cooper of Pharmatech Associates discusses exporting U.S.-manufactured material to foreign markets leveraging a certificate of pharmaceutical product (CPP) issued by the FDA.

"System Impact Assessment: A Risk Managment Framework for a COVID World by Wai Wong"

Wai Wong, Vice President, Validation

The new normal created by the recent COVID-19 pandemic has created disruptions in many sectors of life sciences. In the case of vaccine development, pairing SIA with digital twin modeling can provide invaluable insight into whether your equipment has the necessary capabilities to accept the process.

"Interacting with FDA During Biosimilar Development: From Initial Advisory Meeting to BLA"

Mary Lou Zett, Principal Consultant

Pharmatech’s Mary Lou Zett has mapped out the planning process for the development of a biosimilar from an analytical approach supported by nonclinical and clinical comparability studies, in a two-part series in BioProcess Online. In part one, she details the biosimilar development path. Part two discusses how to prepare for your meetings with the FDA.

"Mapping the Development of a Biosimilar Candidate: Analytical & Regulatory Decisions"

Mary Lou Zett, Principal Consultant

Pharmatech’s Mary Lou Zett has mapped out the planning process for the development of a biosimilar from an analytical approach supported by nonclinical and clinical comparability studies, in a two-part article in BioProcess Online.

In part one, she details the biosimilar development path. In the second part of the article discusses what–and when–to present research findings and how to prepare for your meetings with the FDA.