Solutions and Services

Solutions and Services

Pre-Approval Readiness Programs

GMP Laboratory compliance analysis, GMP Contract Manufacturer analysis, GMP Training, Batch Production monitoring, Batch Record review, and Quality Agreement development.

Supplier Auditing

This can be performed as individual audits or as a part of an ongoing supplier management program.

GCP Auditing

This can be performed as individual audits or as a part of an ongoing Clinical Compliance program.

Solution Hosting

This is provided for our clients who want solutions developed and hosted on an ongoing basis.

Annual Product Reviews

Product Stability Monitoring


Quality Systems development & implementation.

The solutions we provide are Document Management, Change Management, GMP Training systems, Complaint handling, Device History File management, Materials Management, Batch Management, and Incident Management.


Third Party Portal development & implementation.

We interface your organization with your Suppliers and Contract Manufacturers to assure timely and accurate communications. This includes Specification delivery and implementation, Change Request interface, Batch Record delivery, and Deviation management.


Computer Systems Validation (21 CFR Part 11 compliance)