Your Partner In Quality & Compliance

Formulated Solutions is the premier aerosol, barrier pressurized pack, semi-solid, tube, liquid and bag-on-valve contract manufacturer for highly regulated products, including those regulated by the U.S. Food and Drug Administration. We regularly support quality audits by governmental regulatory bodies and many of the largest Consumer Healthcare companies in the world, averaging more than 2.5 per month. We stand audit-ready and have a spectacular regulatory history.

  • Micro Testing
  • Analytical Testing
  • Methods Development
  • Quality Testing
  • Stability Studies
  • Dedicated Project Management
Key Stats

ISO 8

nine blending suites

ISO 8

six production suites

ISO 5

aerosol filling

600,000

cubic feet of environmentally controlled GMP production space

100,000

square-foot climate controlled offsite warehouse

Operational Excellence

In today’s Consumer Healthcare landscape, quality isn’t a competitive advantage — it is the price of entry. We know how important quality and regulatory compliance are to the success of your product and your business, which is why we are here — to ensure these standards are consistently met throughout the entirety of your project, filling in the gaps in your institutional knowledge that can translate to costly failures if left unaddressed.

The biggest thing lacking in the industry, but which Formulated Solutions has, is a strong understanding of regulations ... We don’t know what we don’t know. A good partner needs to fill that gap.

Zubin Meshginpoosh, President & CEO, Santus Labs

Commercial Success

Since our inception, we have demonstrated an exemplary regulatory track record, successfully helping to commercialize more than 600 products, and have fostered a profound understanding of global regulations in the 46 countries for which we manufacture products. When you partner with us, you can be confident your project — and your product — meets all relevant regulatory and health guidelines.

Quality_-image
Sophistication in compliance is the strongest thing we look for.

Michael Tune, Vice President, Personal Care Development Center, Bayer

Registrations

  • Certified cGMP Facility
  • FDA Approved for Rx, OTC and Medical Device
  • EPA
  • ATF
  • Florida Department of Health
  • Florida Bureau of Pharmacy
  • Health Canada
  • Korean Ministry of Food & Drug Safety
  • ANVISA
  • EMA (EU)
  • TGA
  • USDA Organic Certified