Outsourcing

Feliza Mirasol is the science editor for 

Podcasts

Following disruption in the bio/pharmaceutical supply chain as a result of the COVID pandemic, the outsourcing industry has learned to adapt and push forward in a climate that is dynamically different. 

Drug Solutions Podcast: Challenges, Sustainability, and Big Trends in Outsourcing Today

Articles

The trends shaping the growth of the biologics outsourcing industry demand attention.

The Logistics of Outsourcing Biologics

Amy Lavelle is associate director at Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific.

Laura Brunner is principal scientist at Bioanalytical Lab, PPD Clinical Research Services, Thermo Fisher Scientific.

When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

When Is It Appropriate to Outsource Bioanalysis Work to a CRO?

Stephan Hütter is associate director, Global Program Management at PharmaLex.

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.

The Next Frontier in Pharmaceutical Outsourcing

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

Pharmalex Launches Major New Service Line, Biopharma Excellence

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

ProductLife Group and Juuka Advisory Partner Up on New Consulting Venture

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.

Contract Services, Regulatory Consulting