Contract Services, Regulatory Consulting

Contractors Balance Increased Demand During COVID-19

July 01, 2020

BioPharm International

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation

June 30, 2020

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

Fifteen Years of Progress: Biopharmaceutical Industry Survey Results

July 01, 2018

BioPharm International

This article highlights 15 years of changes in biopharmaceutical manufacturing.

Operations and Quality Oversight of CMOs

May 15, 2017

BioPharm International

Effective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.

Quality Metrics and CMO Agreement

May 15, 2017

BioPharm International

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

Regulatory Reform in China: Implications for Global Biopharmaceutical Companies

June 15, 2016

BioPharm International

New drug approval policies promote industry growth and injectable contract manufacturing opportunities in China.

Biomanufacturers Demand Higher Quality Standards in 2016

June 15, 2016

BioPharm International

Biopharmaceutical manufacturers continue to put quality at the forefront of their relationships.

Integrating Technology Transfer and Facilities Startup for Biologics

April 01, 2016

BioPharm International

Careful planning, adequate staffing levels, and experienced project managers can help avoid pitfalls of transferring processes from one facility to another.

Overwhelming Response from Industry on FDA’s Guidance on Quality Metrics

December 07, 2015

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

Quality Agreements for Contract Manufacturers

September 01, 2014

BioPharm International

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.