Setting new standards for quality
Setting new standards for quality
We’re dedicated to going beyond just meeting quality standards and redefining them. Our relentless pursuit of excellence sets us apart as a CDMO, ensuring you receive products and services that exceed expectations. Here’s how we do it:
Uncompromising standards:
Our robust quality management system, complete with comprehensive standards and procedures, guarantees continued compliance. We consistently deliver products that meet regulatory requirements.
Quality at every step:
Our end-to-end quality assurance, integrated into every single tiny detail of the product lifecycle, leaves nothing to chance. From initial formulation to post-market surveillance, quality is woven into the very fabric of our process.
Global quality network:
Our team of quality experts provides unparalleled support. We empower you to meet the stringent quality demands of any global market.
Continuous innovation:
We're not content with the status quo. We continually invest in innovation, pushing the boundaries of quality assurance and setting new industry benchmarks.
Proven excellence:
Our track record speaks for itself. With an impressive regulatory history, audits from over 17 regulatory bodies and the trust of most of the top 12 pharmaceutical companies, our commitment to quality is undeniable.
Quality by design
Quality is the foundation of our culture. Our quality by design (QbD) philosophy ensures that quality is ingrained in our products from the very beginning.
We're also driven by a passion for continuous improvement. We're constantly seeking innovative ways to elevate our quality systems and processes. This includes investing in game-changing technologies and empowering our employees with the latest quality standards.
Our unwavering dedication to quality has earned us the trust and loyalty of our clients. We're proud to be a leading CDMO, renowned for our exceptional quality and steadfast compliance.
Registrations and Certifications *
- Certified cGMP Facility
- FDA Approved for Rx, OTC, and Medical Devices
- EPA
- ATF
- Health Canada
- Korean Ministry of Food & Drug Safety
- ANVISA
- EMA (EU)
- TGA
- NSF
*NOTE: This list reflects the compilation of registrations and certifications held individually at each production site. As such, the items listed may not apply to both locations.
Registrations and Certifications *
- Florida Department of Health
- Florida Bureau of Pharmacy
- Tennessee Board of Pharmacy
- Underwriters Laboratories
- USDA Organic Certified
- ISO 9001 Quality Management
- ISO 13485 Medical Devices
- ISO 22716 Cosmetics
- ISO 14001 Environmental Management
- ISO 45001 Occupational Health & Safety
Ever tried the Formulated Solutions approach?
Delivering excellence since 1999 from the forefront of innovation. Pushing boundaries and challenging the status quo underpinned by a bedrock of reliable quality. We're more than just a CDMO – we empower our clients to deliver impact with every action.