Contract Services, Regulatory Consulting

The Next Frontier in Pharmaceutical Outsourcing

February 15, 2022

While companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.

Pharmalex Launches Major New Service Line, Biopharma Excellence

October 14, 2021

Pharmalex has launched the Biopharma Excellence brand, a new service line that combines the expertise of PharmaLex, ERA Consulting, and Biopharma Excellence.

ProductLife Group and Juuka Advisory Partner Up on New Consulting Venture

September 24, 2021

ProductLife Group (PLG) and Juuka Advisory have teamed up to form a new consulting offering, ProductLife Consulting.

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.

Establishing an Effective Data Governance System

November 02, 2017

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

How to Get the Most from Regulatory Outsourcing

September 01, 2017

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

Quality Agreements:Managing Global Relationships

March 02, 2017

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

The Importance of Quality Agreements

March 02, 2017

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

Getting, and Staying, Ahead of Global Quality Demands

February 01, 2017

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

FDA Guidance Helps Further Clarify Quality Agreements

November 28, 2016

PTSM: Pharmaceutical Technology Sourcing and Management

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