Excellence in Quality
Worry-Free Quality and Regulatory Services
Quality Services
Exela Pharma Sciences’ leadership team, and our employees are committed to your overall program success with a strong focus on Quality, Service, and Reliability. Over one-third of our employees are in Quality specific roles. Exela has a successful FDA inspection history as both a commercial manufacturing and commercial pharmaceutical company. Any observations from General Inspections, 503B, PADE, and General & PAI inspections are addressed fully and promptly.
We utilize the following to support our Quality efforts:
Electronic Quality System – For quality monitoring systems, to manage documents, training, and quality functions.
Micro Lab System – Microbiology testing, environmental monitoring activities, and trend analysis are conducted using a state-of-the-art system.
Empower – Chemistry quality control. Analytical chromatography data management.
Building and Equipment – Calibration, validation, and facility maintenance monitoring is done electronically.
Enterprise Resource Planning (ERP) System – Inventory and product release tracking.
Laboratory Information Management System (LIMS) – For product release and quality control management.
Regulatory Services
Exela’s in-house regulatory capabilities represent a core component of our overall commercial manufacturing and commercial pharmaceutical execution strategy. All original and supplemental NDAs and ANDAs, as well as supplements (line transfers or other post-approval manufacturing changes) are drafted, compiled, filed, and prosecuted by an in-house regulatory team. For our CDMO partners, Exela coordinates activities throughout filing, commercialization and scale-up to improve timelines and efficiencies.
Prepare and submit Annual Reports and Periodic Adverse Event Reports.
Pharmacovigilance medical literature monitoring is performed in-house, and other pharmacovigilance activities are outsourced.
Nonclinical/clinical research studies to support filings are outsourced to CROs and the outsourcing activities are managed by the in-house team.
Submit facility annual registrations.