The more difficult your project is to formulate, the harder to fill, the more dogged we will be in relentless pursuit of an optimal solution. We’ve got this.
on-shelf products developed or improved by our team members
unique formulas in production
square feet of combined pharmaceutical facilities
of staff dedicated to a Quality function
Key To Success
Our commitment to remaining true to our R&D and product development roots really sets us apart when it comes time to formulate your drug product. It’s that consultive problem solving lineage, and our broad depth of experience across a range of industries and applications, that enable us to connect seemingly disparate dots to successfully tackle your most complex formulation drug development issues — even if others have failed before. Give us a challenge and watch us get to work for you.
We have a reputation for creative problem solving. There are few things we enjoy more than opening a door that initially looks firmly locked. We look for and embrace new ways of doing things. You’ll never, ever, hear us say, “because this is how we’ve always done it.”
In support of creating a modern, innovative, and collaborative work environment, in 2019 we completed a full build-out of a dedicated Innovation and Development (I&D) work space. Check out the attached video to see the results.
Our expert team of scientists and lab technicians will work alongside your in-house R&D, supply chain, or marketing staff to develop exactly the right formulation and final package for your needs. We call it co-creation, and our uniquely inventive thinking creates tremendous value for our customers.
Our job is to help you create high-quality product solutions that your customers and patients will love, and will love using; that’s why they are on our mind at every step of the development process. Our deep experience and company-wide culture of innovation allow us to hone in on ideal solutions while weeding out those ideas that don’t best serve your customers’ needs.
Always Thinking End User
Another thing always top-of-mind during formulation is adherence. Whether your product is a Branded Rx, NDA or Monographed OTC, or medical device, it’s crucial that your customers actually want to use it, and even love to use it. Optimum formulation ensures correct, consistent usage, and fosters brand loyalty. This is true for all forms that we work with: sprays, foams, gas-emulsions, ointments, powder sprays, single dose wipes, packettes, liquid oral dose, nasal and rectal specialty delivery formats, to film formers or complex solutions or pastes, and so on — and it’s also true for the exciting new forms and applications that we will create in the future.
We are problem solvers. We create value by listening to your customers’ needs, creating novel application opportunities, developing consumer-focused extensions to existing product lines, and reformulating and improving existing products for an ideal patient experience.
In addition to the ability to develop, validate and transfer methods, we offer a full suite of micro and analytical capabilities. Our services include:
- Turnkey solutions
- New product development and ideation
- Package development and selection
- Specifications development
- Process development
- Material sourcing
- Product pricing simulation and models
- Multi-ICH Zone Stability Programs
- Methods development
- Product scale-up
- Clinical Production
- Full-scale manufacturing
Our 220,000 square foot Corporate Headquarters / Main Production Facility, our second 455,000 square foot Production Facility, and our 125,000 square foot GMP Logistics Support Facility are located across Central Florida and Southern Tenessee and house certified cGMP production facilities and cGLP laboratories. The products we manufacture are shipped to 46 countries around the world. We hold international registrations with the FDA, Health Canada, ANVISA, EPA, EMA, MHRA, ATF, Florida Dept of Health, the Florida Bureau of Pharmacy, UL, and TGA. Our regulatory record is excellent.
That was the cleanest, most organized facility I’ve ever been in.
Chief Operating Officer - Global SkinCare Company
Learn more about how we’ve overcome difficult formulation challenges and achieved market growth for our customers in the case studies linked below.