Complete Vendor Management

Biovalorem’s vendor management approach and tools have been commended by regulatory agencies such as the FDA during their inspections. In managing your universe of unique vendors, suppliers, and consultants, we ensure the following processes are in place:

• Confidentiality Disclosure Agreements (CDAs) that protect you and your future partners best interest
• Master Service Agreements (MSAs) along with the right sized Quality Agreements (QAs) defining the scope of the planned delegated responsibilities
• Robust qualification methods designed based on the risk delegated services have on patient safety, product quality and data integrity as well as to the overall health of your business
• Effective Routine and For Cause audits with an appropriate frequency, scope and approach
• Monitoring of the partner’s performance and predicting the overall vendor risks to your operations

Our compliance expertise and experience covers partners managing activities such as:

• Contract manufacturing for Drug Substance and Drug Products
• Packaging, Labelling organizations
• Product Test Laboratories
• Distribution and Warehousing
• Clinical Research and Clinical Monitoring
• Data Management and Statistics
• Pharmacovigilance
• Central Laboratories and assessment laboratories
• eCRF, eCOA, CTMS, IWRS service and platform providers
• Document Management System providers

As a Sponsor, we know that at the end of the day, you are accountable and for that reason, we strengthen the relationships with your vendors with open communications throughout the process.