Open Position in South Florida

                          Our firm is searching for a Technical Writer for a pharmaceutical client located in South Florida.  As a Technical Writer some of your responsibilities will be: Assessment, improvement, and standardization of business processes including...

Outsourcing facilities must be GMP compliant, though…..

Policies for Outsourcing Facilities Posted 10 December 2018 | By Ana Mulero  The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance...

LEC – Organizational Capability for QA Assessment

Today we would like to introduce you to a process that one of our Quality System SME, Eng. Roberto Correa with his LEC team, designed and validated to perform a Quality Capability within any Life Sciences company in a very short time frame. Utilizing the D-M-A-I-C...