Outsourcing

Articles

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation

Thu Truong, JD, is senior associate of Science and Technology at Lachman Consultants.

Ron George, PhD, is director of Science and Technology at Lachman Consultants, r.george@lachmanconsultants.com 

James Davidson, PhD, is vice-president of Science and Technology at Lachman Consultants.

Data governance is necessary for compliance with current regulatory expectations for data integrity in pharmaceutical R&D and manufacturing organizations.

Establishing an Effective Data Governance System

Joanne Sullivan is corporate vice-president, RegulatoryOutsourcing Services at PAREXEL Consulting.

Philip Smith is senior director, Integrated Product Development at PAREXEL Consulting.

Bettina Goldberg is vice-president, Clinical Trials Regulatory Services at PAREXEL Consulting.

Regulatory outsourcing can result in improved compliance, greater transparency, higher productivity, increased cost-effectiveness, and desired strategic outcomes.

How to Get the Most from Regulatory Outsourcing

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.

Quality Agreements:Managing Global Relationships

Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, susan.haigney@ubm.com.

Pharmaceutical Technology asked Siegfried Schmitt, principal consultant at PAREXEL, about the importance of quality agreements in the sponsor/contractor relationship.

The Importance of Quality Agreements

Mike Jovanis is the vice president of product management at Sparta Systems

More life-sciences companies are starting to manage global suppliers holistically.

Getting, and Staying, Ahead of Global Quality Demands

Although both sponsor and contract partner must comply with quality regulations, regulators say the final responsibility for quality lies with the sponsor

FDA Guidance Helps Further Clarify Quality Agreements

David Deere is the chief commercialization officer for PaizaBio, a US-based contract manufacturing organization and consulting group with in-country aseptic fill-and-finish operations in Hangzhou, China. Deere is a veteran global pharmaceutical executive whose career path includes Valeant Pharmaceuticals International, F. Hoffman-La Roche and Genentech.

Quality, innovation, and new approval pathways open drug development options for the Chinese market, including injectable contract manufacturing.

Regulatory Reform in China Creates Opportunities

Agnes Shanley is senior editor of Pharmaceutical Technology.

Training and mock audits are the key to preventing data integrity issues with partners offshore, but the process must start at home. Compliance consultant John Avellanet shares best practices and ways to minimize costs.

Offshore Supplier Quality: Trust, But Verify

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Contract Services, Regulatory Consulting