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Formulated for solutions. For success. For you.

Our formulation and process development services are designed to champion your vision and transform it into the next market triumph. Our team of ingenious innovators is dedicated to transforming your concepts into commercially successful products that both captivate your target audience and deliver tangible benefits.

Apply the right formula and success is inevitable. 

Our core formulation and process development capabilities are your blueprints for success: 

  • Integrated approach: Our formulation and process development teams operate as one cohesive unit, ensuring your product is designed for seamless manufacturability from the very beginning. This eliminates costly delays and scale-up issues, saving you valuable time and resources.
  • Quality by Design (QbD): Quality is not an option. We carefully consider solutions and optimize processes, embedding quality into every stage of development. Our rigorous QbD approach guarantees your product not only meets but exceeds the most stringent quality and compliance benchmarks.
  • Flexible, tailored solutions: Your product is unique. That's why we design solutions just for you that perfectly fit your every need. Whether it’s help with a single development step or a complete turnkey solution, we have what you need to get your product exactly where you need it, when you need it.
  • State-of-the-art equipment: Our facilities are equipped with the latest technology in formulation and process development. High-shear mixers, homogenizers, filling lines – these are the tools that enable us to develop and scale your product rapidly and efficiently, giving you a competitive edge in the market.

Overcoming challenges, exceeding expectations

We have a proven track record of overcoming challenges and delivering complex formulation and process development projects. From packaging failures and stability issues to scale-up hurdles, we consistently deliver innovative solutions that not only resolve problems but also lead to new intellectual property for our clients. 

We're not just another CDMO. We're your strategic partner, committed to bringing your vision to life.

  • R&D and product development heritage: With deep roots in R&D and product development, we offer a consultative, solution-oriented approach. Extensive cross-industry experience enables us to connect the dots and tackle your most complex formulation challenges head-on.
  • Creative problem solving: We thrive on accepting even your most difficult challenges. We are relentless problem solvers, constantly pushing boundaries and developing innovative solutions.
  • Customer centricity: Your customers are our priority. We will help you ensure they will love using your product. Our experience and innovation allow us to pinpoint ideal solutions that perfectly meet their needs.
  • Adherence and compliance: Whether it's a new drug application (NDA), OTC, or medical device, we optimize formulations to drive compliance and brand loyalty across all product forms.
  • Value creation: We are more than just problem solvers; we are value creators. We listen, we identify novel opportunities, and we develop products that deliver an optimal user experience.

Services that add value and accelerate success

Beyond our core services, we offer a comprehensive suite of capabilities, including:
  • Turnkey solutions
  • New product development and ideation
  • Phase I-III development
  • Package development and selection
  • Specifications development
  • Process development
  • Material sourcing
  • Clinical and commercial supply
  • Product pricing simulation and models
  • Multi-ICH Zone Stability Programs
  • Methods development
  • Technology transfer
  • Product scale-up   
  • Microbiology

 

About us (1)

Frequently Asked Questions About Technology transfer and commercialization

How do I transfer an existing pharmaceutical product to a new CDMO?

A successful technology transfer normally includes review of the formulation, master manufacturing record, raw materials, process parameters, analytical methods, specifications, stability data, packaging components and regulatory commitments. The receiving CDMO then translates that knowledge into its equipment and quality system before validation and commercial production. 

Can Formulated Solutions take over an existing commercial product from another manufacturer?

Yes. Formulated Solutions supports technology transfers of established commercial products into its U.S. manufacturing network, including assessment, process transfer, analytical transfer, scale-up, validation, packaging and ongoing commercial supply.

Can a company move manufacturing back to the United States?

Yes. Existing products can be transferred from overseas or domestic manufacturing operations into qualified U.S. facilities. Formulated Solutions operates manufacturing sites in Largo, Florida and Cleveland, Tennessee and can evaluate products for transfer into its U.S. network.

What information does a CDMO need to evaluate a technology transfer?

Typical information includes the formulation, annual volumes, batch size, manufacturing process, equipment requirements, analytical methods, specifications, stability information, packaging configuration, regulatory status and expected timing.

Can Formulated Solutions help scale a laboratory formulation to commercial production?

Yes. Formulated Solutions integrates formulation and process development so manufacturability is considered during development rather than only after a formula is complete. Programs can progress from proof of concept and pilot production through commercial-scale manufacturing.

Can Formulated Solutions support clinical batches before commercial launch?

Yes. Formulated Solutions supports appropriate non-sterile Rx programs from development and clinical or bridging supply through scale-up and commercial production.

Can Formulated Solutions rescue a difficult development or manufacturing project?

Formulated Solutions’ technical teams work on challenging formulations, processes and delivery systems. Its combination of formulation science, process development, packaging engineering, analytical capabilities and commercial manufacturing allows problems to be evaluated as an integrated system rather than as isolated formulation or manufacturing issues.

Can Formulated Solutions take over manufacturing of a product made at another site?

Yes. Formulated Solutions can evaluate transfers of development-stage and commercial products from sponsors or other CDMOs. A transfer may include documentation review, analytical method transfer, engineering batches, and process validation, depending on the program.

How long does a technology transfer typically take?

Timing depends on the completeness of the technical package, method transfer, equipment fit, product complexity, and any regulatory filing needed for the site change. Formulated Solutions develops a milestone-based timeline for each program.
This builds on the current site’s general timeline answer; don’t publish a fixed 6–9 month estimate unless the team confirms it.

What information is needed to start a technology transfer?

A transfer package typically includes the master batch record, formulation and specifications, analytical methods and validation reports, stability data, and process history, including known deviations. The required documents depend on the product and transfer scope.

What clinical stages does Formulated Solutions support?

Formulated Solutions supports programs from early clinical supply through later-stage development and commercial manufacturing. Confirm the exact phase range and project fit with the team before publication.

What batch sizes can Formulated Solutions manufacture?

Batch size depends on the product, process, equipment, and program stage. Formulated Solutions can assess clinical, pilot, and commercial requirements for each project.
Add a specific range only after Operations confirms the figures and units.

How does Formulated Solutions scale a liquid or semi-solid from clinical to commercial production?

Scale-up evaluates critical process parameters—such as mixing, temperature, and shear—rather than relying on batch volume alone. Pilot or engineering work can help establish that the process consistently meets product requirements before validation.

Does Formulated Solutions support process validation?

Yes. Process validation follows a lifecycle approach that includes process design, process performance qualification, and continued process verification, as applicable to the program.

What formulation challenges are considered when developing a topical foam?

Development may need to address API solubility or suspension, physical and chemical stability, rheology, dose consistency, foam performance, and compatibility with the dispensing system. The priorities depend on the product and its goals.

How can formulation and process choices affect foam consistency?

Ingredients and manufacturing conditions can affect a foam’s structure, texture, and dispensing performance. Formulation and process development may evaluate variables such as ingredient order, temperature, homogenization, and rheology controls.

Ever tried the Formulated Solutions approach?

Infused with ingenuity.

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.