Quality Commitment

Quality in Every Last Molecule

We won’t just meet your expectations. We’ll redefine them.

As a drug developer, you’re facing two enormous challenges. You need to get to market fast, but you need to get there with a product that’s safe and effective. Speed without quality puts patients at risk; quality that’s slow-moving puts your business at risk.

To succeed, you need to keep both in balance.

We are masters of that balancing act. Our clients trust us to hit every manufacturing milestone on our way to delivering superior drug products that sail through regulatory approvals.

We do this by applying the principles of Quality by Design (QbD) to every last detail of our process, from how we approach API sourcing and early feasibility studies all the way through commercial scale-up and FDA approval.

This holistic approach to quality helps us to remove barriers that typically slow production and to identify opportunities and solutions that others overlook.

Quality in Our Track Record

Our history of regulatory approvals and commercial product launches is our strongest testament of this commitment to quality. With roots that reach 100 years into the past and a vision of a future in which every good idea gets to market, we’re continuously making a difference for our clients, one success story at a time.

Quality in Our Regulatory Submissions

One of the best ways to see our QbD approach in action is by experiencing the difference of a truly integrated team. From day one, our senior regulatory specialists, who offer more than 75 years of combined experience, work shoulder-to-shoulder with our R&D team to assess risks, streamline tech transfers, and ensure that your submission is positioned for a successful and streamlined regulatory outcome.

Quality in Our API Manufacturing Network

The manufacturers in our extensive global network are FDA-approved, but we don’t stop there. Our API sourcing specialists, strategically based out of Israel, conduct frequent on-site audits of each manufacturer, ensuring continuous quality and reliability.

The breadth of this prequalified network helps us to find solutions that others miss and negotiate favorable deals for our clients, even in times of supply chain insecurity. To date, we’ve successfully imported and cleared thousands of API shipments.   

Quality in Our Warehouse and Facilities

We offer more than 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, featuring the flexible technologies and automated solutions we need to get our CDMO clients to market faster, no matter their dosage form. Our portfolio includes DEA-licensed locations for Class II-V controlled substances. 

API Sourcing

Our strong relationships with world-class manufacturers around the globe reduces supply chain risks and improves your access to high-quality APIs.

API Products

No matter how niche or complex your active pharmaceutical ingredient, LGM Pharma can secure it, import it, and deliver it to your door.

CDMO Services

From concept through commercialization, LGM Pharma’s full-service CDMO will get your product to market faster—no matter your dosage form.

Analytical Services

Protect patient health and your bottom line with a full continuum of analytical method development and stability testing for APIs and drug products.