White Paper Archives
Early Phase Drug Development & Cold Storage Vendor Qualification
By Enith Morillo, M.S., Quality Assurance Consultant
The need for phase-appropriate vendor management programs is on the rise as biotech start-ups and early-phase drug development companies continue to emerge. In addition to utilizing risk management as a tool to differentiate critical from non-critical vendors, companies need a strategy to determine whether vendors are required to support the product lifecycle…Read More.
Aseptic Processing: Key Differences between EU and US FDA
Complya Consulting Group in collaboration with McGee Pharma International
In collaboration with McGee Pharma International (MPI), Complya Consulting Group is pleased to offer this joint white paper which explores significant differences between Food and Drug Administration (FDA) and European Medicines Agency (EMA) requirements for aseptic processing… Read More.
Clinical Materials: Changes and Comparability
By Jilla Boulas, Senior Regulatory Affairs Consultant
The development of a drug product is a long and costly journey which starts from basic research and moves down a path that requires much development, and takes turns at points where decisions have to be made…Read More.
Leveraging Third-Party Audits in the Pharmaceutical, Biotechnology & Medical Device Industries
By Daniel Fishman, Senior Quality Assurance Consultant
Those of us in the competitive and highly regulated pharmaceutical, biotechnology and medical device industries understand the need to balance operational efficiency with regulatory compliance. We must find ways to reduce complexities, eliminate redundancies and streamline operations while staying compliant with an array of regulations, guidance documents and regulatory expectations (some explicit, others less so)…Read More.
Complya’s “Virtual Toolbox” Provides A to Z Support for a Virtual Drug Development Company
Development of FDA-compliant and sustainable quality systems for virtual and semi-virtual biotechnology and pharmaceutical companies is a critical component of a company’s growth. In their May 2013 Draft Guidance on Contract Manufacturing Arrangements for Drugs: Quality Agreements, FDA clarified their expectations for virtual companies regarding responsibility for GMP compliance and oversight of contract manufacturing and testing facilities…Read More.
The Quarterly Consult Archives