Pharmaceutical Contract Manufacturing and Quality Management

Sovereign Pharmaceuticals is the best CDMO Pharmaceutical Company in America. We are committed to our customers and maintaining quality and regulatory requirements. We do this via dedicated, empowered, and motivated employees. At Sovereign, pharmaceutical formulation is at the heart of what we do. From oral to topical, liquids to solids, we've got all your A's, N's, and D's covered.

Manufacturing Capabilities

With Sovereign, you will find the most comprehensive all-in-one operation possible for virtual pharmaceutical companies. We have decades of experience bringing together the large-scale manufacturing and packaging solutions your company needs to make its mark in the industry.

At Sovereign, we specialize in pharmaceutical manufacturing of customized dosage forms. These include immediate, sustained, and modified release. Sublingual; quick-dissolving; chewable; bilayer and coated tablets; powder-filled capsules, and bulk powders. We also manufacture oral solutions, topical solutions such as otic preparations, and oral suspensions.

These products are all developed at our facilities with our own manufacturing equipment. We are a full-service contract manufacturing company. After development, all the products are also packaged. We handle all aspects from the label design to each different sizes of packaging.

Quality Management

Before our products can be ready, quality management is necessary. Sovereign maintains an excellent relationship with the FDA, DEA, and local health and regulatory agencies. Our quality management comprises three main components.

1. Quality Assurance

This department is responsible for managing and providing oversight for the quality systems at our pharmaceutical company in Texas. Each batch manufacturing cycle begins and ends with quality assurance, but depends on each department following the quality systems and maintaining cGMPs to produce quality products. QA issues the manufacturing lot numbers and the appropriate record, reviews/approves each executed record, the analytical data and stability reports.

2. Quality Control

The quality control department is a team of dedicated and hardworking degreed professionals who are highly trained in pharmaceutical analysis and cGMP regulations. This team is responsible for testing both the raw and finished products. Testing includes stability, in-process, process validation, and microbial samples. 

Everything done here is to maintain stringent quality and ensure the customer that their products follow the strictest guidelines.

3. Quality Engineering

The quality engineering department is responsible for Process Validation, Equipment Qualification, and Cleaning Validation. The engineering team generates and executes validation protocols to demonstrate that process, equipment, and system consistently produce products or results that meet pre-approved specifications. This team also performs engineering studies to support proposed changes to processes and procedures toward optimization and improvements.

Conclusion

Contact Sovereign Pharmaceuticals to learn how we can assist your manufacturing needs. We are a pharmaceutical formulation company that stands out. We're ready to talk with you about your CDMO needs, and determine if we will be a good fit for each other. Please don't hesitate to reach out. Contact us today.