Formulated Solutions
Explore frequently asked questions about our CDMO capabilities, dosage forms, development services, manufacturing, quality systems, packaging, and partnerships.
Formulated Solutions is a U.S.-based contract development and manufacturing organization (CDMO) serving the OTC, prescription, cosmetic, and medical device markets. We operate two GMP-compliant facilities in Largo, Florida and Cleveland, Tennessee, offering full-service support from formulation development through commercial manufacturing and packaging.
A CDMO, or contract development and manufacturing organization, partners with brands to develop, scale up, and manufacture products on their behalf. Formulated Solutions serves this role for OTC, Rx, medical device, and cosmetic brands, managing everything from early formulation through commercial-scale production.
Formulated Solutions operates two U.S. manufacturing facilities, located in Largo, Florida and Cleveland, Tennessee, together providing more than 800,000 square feet of GMP production and warehousing space.
Formulated Solutions brings more than 25 years of manufacturing experience, supporting leading consumer healthcare and pharmaceutical brands across formulation development, technology transfer, and commercial production.
Formulated Solutions serves the OTC, prescription, cosmetic, personal care, nutraceutical, and medical device markets, supporting categories such as nasal health, antifungals, pain relief, skin health, and hygiene.
Formulated Solutions partners with companies of all sizes, from early-stage brands developing a first product to large, globally recognized consumer healthcare companies with established commercial portfolios.
Formulated Solutions develops and manufactures a broad range of prescription (Rx), over-the-counter (OTC), cosmetic, medical device, and personal care products across numerous therapeutic categories.
Our experience includes:
From formulation development and analytical testing to commercial manufacturing and packaging, Formulated Solutions provides end-to-end CDMO support across these product categories.
Formulated Solutions develops and manufactures products across multiple regulated healthcare and consumer product categories, including:
Our integrated CDMO capabilities include formulation development, analytical testing, regulatory support, scale-up, commercial manufacturing, and packaging. We work closely with customers to bring products to market across a wide variety of therapeutic categories, dosage forms, and delivery systems.
Yes. Formulated Solutions supports Class I and Class II medical device assembly.
Yes. Formulated Solutions' development team supports natural, clean-label, and free-from formulations, developed without ingredients such as parabens, sulfates, or synthetic fragrances, depending on product category and regulatory requirements.
Yes. Formulated Solutions has extensive experience developing and manufacturing topical analgesic and pain relief products, including creams, gels, lotions, sprays, foams, roll-ons, and other topical dosage forms. We support products regulated under OTC Monograph, OTC NDA, and prescription (Rx) pathways, providing formulation development, analytical support, scale-up, commercial manufacturing, and packaging. Our expertise includes products containing common analgesic active ingredients as well as combination therapies designed to improve patient experience and product performance.
Formulated Solutions manufactures a broad range of pharmaceutical dosage forms and packaging formats, including aerosols, nasal sprays, airless bottles, pumps, jars, tubes, rollerballs, Bag-on-Valve (BOV) systems, metered-dose products, and traditional bottles. We help customers select the optimal delivery system based on formulation requirements, patient experience, and commercial objectives while supporting development through commercial production.
Formulated Solutions specializes in technically demanding delivery systems, including aerosols, bag-on-valve, foams, and nasal sprays, along with specialty formats like vapo-coolant and cryoablation sprays that require precise formulation and process control.
Yes. Formulated Solutions offers both contract manufacturing of a brand's proprietary formulation, private label and white label programs using established formulations, giving partners flexibility based on timeline and budget.
Yes. Formulation IP developed specifically for a partner can be structured as exclusive to the brand, co-owned, or retained by Formulated Solutions, depending on the development agreement.
Yes. Formulated Solutions partners with international brands seeking U.S.-based manufacturing to establish a U.S. supply chain, meet FDA requirements, or enter the U.S. market. We currently ship to 46+ countries worldwide.
Yes. Formulated Solutions routinely signs NDAs with prospective partners before discussing proprietary formulation or technical details, protecting both parties from the earliest conversations.
Yes. Formulated Solutions welcomes prospective partners to tour our Florida and Tennessee facilities as part of the evaluation process, offering direct visibility into our equipment, quality systems, and team.
Formulated Solutions approaches every relationship as a long-term partnership, staying engaged from early formulation through commercial scale-up and ongoing quality and supply performance.
Formulated Solutions maintains documented processes for capturing, investigating, and responding to product complaints and supporting adverse event reporting in coordination with partners.
Every batch moves through documented in-process and finished-product testing, including analytical and, where applicable, microbiological testing, before release under our cGMP-compliant quality system.
Formulated Solutions' facilities are subject to periodic inspection by the FDA and applicable domestic + international authorities, and we maintain a sustained, impressive inspection history supported by continuous internal quality oversight.
OTC Monograph products meet FDA pre-approved standards for a category, while OTC NDA products require individual FDA review, typically for ingredients or claims outside the monograph. Formulated Solutions manufactures both.
Yes. Formulated Solutions maintains in-house real-time and accelerated stability programs to establish and support shelf-life claims for new and existing formulations.
Formulated Solutions maintains documented batch records from raw material receipt through finished-product release, supported by validated analytical methods consistent with cGMP data integrity requirements.
Formulated Solutions manages regulatory label review, ingredient review, and technical justification, and can coordinate with a partner's design resources or outside vendors for artwork production.
Timelines vary by project type; technology transfer of an existing formulation typically moves faster than ground-up development. Formulated Solutions builds a milestone-based timeline specific to each program early in the partnership.
Yes. Formulated Solutions regularly supports multiple SKUs and product lines concurrently across our Florida and Tennessee facilities, managing complex, multi-SKU portfolios with consistent quality.
Formulated Solutions' facilities include GMP-compliant warehousing that supports staging, storage, and coordinated shipment of finished goods aligned with partner distribution needs.
Formulated Solutions' two U.S. facilities in Largo, Florida and Cleveland, TN provide layered redundancy, allowing many products and processes to be supported at either site if one facility experiences a disruption.
Formulated Solutions supports packaging and component selection, matching bottles, tubes, pumps, and aerosol dispensing systems to the formulation, and can coordinate with a partner's design resources for structural or graphic design.
Yes. Formulated Solutions supports packaging formats incorporating post-consumer recycled (PCR) content and works with partners to evaluate sustainable packaging options that meet performance and brand goals.
Formulated Solutions supports sustainability through PCR packaging options, production efficiency across our facilities, and ongoing evaluation of environmentally responsible formulation and packaging practices.
Formulated Solutions maintains an active presence in the industry through participation in events such as CPHI, CHPA, DCAT, Contract Pharma, SATA, and Cosmoprof, reflecting our ongoing commitment to industry leadership and partnership.
Formulated Solutions develops and manufactures a comprehensive range of topical dosage forms for pharmaceutical, OTC, cosmetic, and personal care products. Our capabilities include creams, lotions, gels, ointments, foams, sprays, and other specialized topical delivery systems. We support customers from formulation development through analytical testing, scale-up, commercial manufacturing, packaging, and regulatory support.
Yes. Formulated Solutions manufactures topical creams for prescription, OTC, and consumer healthcare applications. Our integrated CDMO services include formulation development, process optimization, commercial manufacturing, filling, packaging, and quality support to help customers bring high-quality products to market.
Yes. Formulated Solutions manufactures topical lotions designed for pharmaceutical, cosmetic, and personal care markets. We provide formulation expertise, analytical support, commercial manufacturing, packaging, and regulatory guidance to help customers successfully develop and commercialize their products.
Yes. Formulated Solutions develops and manufactures topical gel formulations for a variety of regulated healthcare and consumer applications. Our experience includes formulation development, stability testing, scale-up, commercial manufacturing, and packaging.
Yes. Formulated Solutions manufactures topical ointments for pharmaceutical and OTC applications while supporting customers through formulation development, analytical testing, commercial manufacturing, packaging, and regulatory support.
Yes. Formulated Solutions develops and manufactures topical foams for prescription, OTC, and consumer healthcare markets. We help customers develop innovative foam formulations while supporting scale-up, commercial manufacturing, packaging, and quality management throughout the product lifecycle.
Yes. Formulated Solutions manufactures both prescription and OTC topical products in FDA-registered, cGMP-compliant facilities. Our integrated development and manufacturing capabilities help customers successfully navigate formulation, analytical testing, validation, manufacturing, packaging, and commercialization.
Formulated Solutions develops and manufactures a variety of nasal drug products for prescription and over-the-counter applications. Our capabilities include metered-dose nasal sprays, squeeze nasal sprays, and other liquid nasal delivery systems. We support customers through formulation development, analytical testing, scale-up, commercial manufacturing, packaging, and regulatory support.
Yes. Formulated Solutions manufactures metered-dose nasal spray products designed to deliver consistent and accurate dosing. Our integrated CDMO services include formulation development, device compatibility evaluation, analytical testing, commercial manufacturing, and packaging to support successful product commercialization.
Yes. Formulated Solutions develops and manufactures squeeze nasal spray products for pharmaceutical and OTC markets. We help customers optimize formulation performance, packaging compatibility, manufacturing processes, and regulatory compliance throughout development and commercialization.
Yes. Formulated Solutions manufactures both prescription and OTC nasal products in FDA-registered, cGMP-compliant facilities. Our experienced development and manufacturing teams support customers from formulation and analytical testing through validation, commercial manufacturing, packaging, and ongoing supply.
Formulated Solutions provides end-to-end support for nasal product development, including formulation development, analytical method development, stability testing, process optimization, scale-up, commercial manufacturing, packaging, and regulatory support. Our collaborative approach helps customers efficiently advance products from concept through commercialization.
Formulated Solutions supports a wide range of primary packaging formats for pharmaceutical, OTC, cosmetic, and medical device products, including bottles, jars, standard and metered-dose pumps, tubes, aerosol cans, bag-on-valve systems, and nasal delivery units. We work with customers to match packaging and delivery systems to formulation, regulatory, and brand requirements from early development through commercial launch.
Yes. Formulated Solutions fills and packages products in a variety of bottle formats, including HDPE, PET, and post-consumer recycled (PCR) options. Our filling lines support liquids, semi-solids, and pump- or spray-dispensed formulations, with packaging selected to protect product stability and meet regulatory and brand requirements.
Yes. Formulated Solutions fills and packages products in jars for creams, ointments, gels, and other semi-solid formulations. Our packaging teams work with customers to select jar materials and closures that support product stability, usability, and shelf presentation.
Yes. Formulated Solutions offers metered-dose pump packaging designed to deliver consistent, accurate dosing for topical, oral liquid, and nasal products. We evaluate pump and formulation compatibility during development to help ensure reliable performance from first use through the end of the product's shelf life.
Yes. Formulated Solutions offers standard, non-metered pump packaging for lotions, creams, gels, and other liquid and semi-solid products. Standard pumps are commonly used where consistent, high-volume dispensing is needed without the precision-dose requirements of a metered system, and our team helps determine the right fit based on product viscosity and use case.
Formulated Solutions works with customers early in development to evaluate delivery system options, including bottles, jars, standard and metered-dose pumps, aerosols, bag-on-valve, and nasal formats, based on formulation characteristics, target dose or usage pattern, regulatory pathway, and brand positioning. This consultative approach helps ensure the packaging and delivery system selected supports both product performance and commercial success.
