Analysis Paralysis: Navigating Early-Phase Analytical Validation
Keys To Successful Blinded Labeling
Evaluation And Management Of Vendor-Qualified Thermal Solutions
Strengthen Your IND Submission To The FDA By Conducting Microbial Challenge Studies
Which Testing Does An Effective Certificate Of Analysis Include?
Establishing a Successful Supply Chain for High Value Products
Establishing a Remote Audit Process as a CDMO
The effects of the pandemic have been far reaching within the pharmaceutical industry and compliance audits have not been immune. Widespread travel restrictions and adjusted visitor policies have prevented standard onsite audits from occurring. As a CDMO, Singota had to pivot to provide clients with transparent and robust compliance audits. This article will dive into the process of establishing a remote audit process and how Singota implemented various changes to acclimate to the new norm.
Analytical Instrumentation – Advancing and Maintaining CDMO Capabilities
CDMOs in the pharma industry rely heavily on state-of-the-art instrumentation to bring their client’s products from drug development through drug manufacturing to the patient. To better serve their client’s needs as technology and the industry advances, a CDMO must know when to acquire new and emerging technologies, increase their overall instrument capacity, and continually maintain their existing validated instrumentation.
Key Metrics to Improve Pharmaceutical Shipping Programs
Just as you wouldn’t decide upon a large purchase without gathering the information required to make an informed decision, our pharmaceutical shipping programs deserve the same attention. Gathering metrics and using them to determine optimal solutions on an individual shipment basis is easier than you think and will improve your performance as well as protect your valuable pharmaceutical products to ensure viability.










