Formulated Solutions FAQ's

Formulated Solutions stands apart by combining pharma-grade quality with deep expertise in advanced delivery systems, supported by an impressive and sustained regulatory inspection history. While many CDMOs offer broad, generalized capabilities, we specialize in complex dosage forms where precision, reliability, and regulatory rigor are critical to success, including liquids, aerosols, nasal sprays, semisolids, foams, and proprietary Whipped Delivery systems.

Key differentiators include:

- A strong and consistent regulatory track record, with successful inspections across FDA and multiple global health authorities, reflecting disciplined quality execution and long-term compliance
- Redundant U.S. manufacturing at two sites, with layered redundancy both within and across facilities, supported by multiple blending and filling lines
- End-to-end, in-house capabilities, spanning formulation development, feasibility, tech transfer, analytical testing, stability, regulatory support, manufacturing, and full commercial scale
- Advanced delivery system leadership, including aerosols, foams, bag-on-valve, nasal, and proprietary whipped technologies that demand high technical and quality rigor
- Proven experience with large global brands, supporting high-volume programs, seasonal demand spikes, and long product lifecycles
- A problem-solving culture, where customers often engage us to resolve complex development or manufacturing challenges that others could not

At our core, we operate as a long-term partner rather than a transactional supplier, aligning regulatory excellence, technical depth, and scalable manufacturing to help customers bring differentiated products to market with confidence.

Formulated Solutions manufactures a broad range of non-sterile, small-molecule products across prescription (Rx), over the counter (OTC), Class I and Class II medical devices, personal care, nutraceutical, and operating suite–leveraged applications. These products are used across self-directed consumer care, physician-dispensed channels, plastic surgery and aesthetic practices, dermatology offices, and other clinical and procedural settings.

Our capabilities include:

- Liquids
- Semi-solids, including creams, gels, and ointments
- Alcohol- and water-based formulations
- Oral solutions and suspensions
- Nasal sprays and mists
- Aerosols
- Bag-on-valve (BOV) systems
- Whipped foams and mousse delivery systems

These capabilities allow us to support products from early development through full commercial production across both regulated and consumer health markets, serving patients, providers, and consumers alike.

Yes. Formulated Solutions provides comprehensive formulation development and technical troubleshooting support across regulated and consumer health products. Our development teams are frequently engaged to create custom formulations, improve existing products for elegance, efficacy, or stability, and convert conventional liquids into advanced delivery systems such as foams, aerosols, and bag-on-valve (BOV) formats.

Many partners come to us after unsuccessful development efforts elsewhere, and our teams are regularly able to resolve complex, long-standing formulation and commercial manufacturing challenges.

Absolutely. Formulated Solutions has deep experience executing successful technology transfers and considers this a core strength. Our tech transfer process includes turnkey analytical method review, pilot and engineering batches, scale-up, process validation, commercial stability programs, and full commercial readiness. We support technology transfers across OTC, prescription (Rx), medical device, nutraceutical, and cosmetic programs, helping partners move efficiently from development or legacy manufacturing into reliable, scalable U.S.-based production.

Formulated Solutions supports a broad range of regulated product categories, including prescription (Rx), OTC NDA, OTC Monograph, Class I and Class II medical devices, and cosmetics. Our facilities and Quality Management System maintain certifications, registrations, and approvals recognized by regulatory authorities worldwide, including:

- U.S. Food and Drug Administration (FDA)
- Health Canada
- ANVISA (Brazil)
- Therapeutic Goods Administration (TGA, Australia)
- Korean Ministry of Food and Drug Safety (MFDS)
- Medicines and Healthcare products Regulatory Agency (MHRA, UK)
- European Medicines Agency (EMA)

In addition, we hold industry-leading quality, safety, and environmental certifications, including:

- ISO 9001 – Quality Management
- ISO 13485 – Medical Devices
- ISO 22716 – Cosmetics GMP
- ISO 14001 – Environmental Management
- ISO 45001 – Occupational Health & Safety
- cGMP, UL, NSF, and USDA Organic certifications

We also manufacture select products that meet Kosher certification requirements, depending on customer needs.

Yes. Formulated Solutions offers robust in-house analytical, stability, and regulatory support to ensure product quality, compliance, and readiness for market. Our capabilities include full analytical method development and validation, in-house real-time and accelerated stability programs, finished product and raw material testing, and regulatory documentation support, including label review.

We also assist with OTC monograph compliance, NDA and ANDA support, and medical device submissions, helping partners navigate regulatory requirements with confidence.

Minimum order quantities at Formulated Solutions vary by product format and packaging configuration. Most commercial programs typically begin in the range of 50,000–75,000 units per SKU, while larger-scale programs can scale to tens of millions of units annually. For development, feasibility, or early-stage programs, we can support smaller batch sizes depending on project needs, equipment requirements, and regulatory considerations.

 

Yes. Formulated Solutions is known for proprietary and advanced delivery innovations designed to enhance product performance, user experience, and brand differentiation. Our platforms include eN2fused™ “Whipped” technology for premium creams and cosmetics, bag-on-valve (BOV) dispensing for pressurized 360-degree application, advanced foam platforms for dermatology, pharmaceutical, and OTC applications, and functional aerosol systems supporting pain relief, antifungal, hygiene categories, and more.

Formulated Solutions supports a wide range of regulatory pathways across pharmaceutical, medical device, and consumer health markets. Our experience includes:

- OTC products, including Monograph and NDA pathways
- Prescription (Rx) programs, including NDA and ANDA topical, nasal, and oral liquid products, as well as clinical supply
- Medical devices, including non-sterile topical Class I and Class II devices
- Nutraceuticals, including oral liquids, functional sprays, and tinctures
- Cosmetics and personal care products

This breadth allows us to guide partners through development, scale-up, and commercialization across multiple regulatory frameworks while maintaining compliance, quality, and speed to market.

Formulated Solutions operates more than 800,000 square feet of GMP manufacturing and warehousing space across two U.S. facilities in Florida and Tennessee. This footprint provides the scale and flexibility to support programs ranging from small pilot and clinical runs through multi–tens-of-millions of units annually.

Our network includes high-speed aerosol lines, high-speed liquid filling lines, and multiple semisolid processing suites, creating redundancy within and across sites and enabling efficient scaling for both seasonal demand spikes and steady-state commercial production.

Formulated Solutions supports a wide range of primary packaging formats designed to meet the needs of regulated pharmaceutical, medical device, and consumer health products. Our supported formats include:

- Bottles, including HDPE, PET, and PCR options
- Tubes, including aluminum and laminate
- Pumps and spray systems
- Aerosol cans, including steel and aluminum
- Bag-on-valve (BOV) systems
- Airless packaging systems
- Mists and droppers
- Metered-dose nasal delivery units

This breadth of packaging capability allows us to align formulation, delivery system, and user experience across self-directed consumer care, physician-dispensed products, and clinical applications.

Yes. Our two manufacturing sites in Florida and Tennessee provide layered redundancy both within and across facilities, supported by a wide range of blending and filling sites. This allows us to run dual-suite production on major brands, strengthen supply chain resilience, support seasonal demand spikes, and reduce the risk of supply interruption.

 

Initial scoping can begin immediately upon engagement. Full scoping of development or technology transfer typically occurs within 2–4 weeks. Overall timelines may vary based on documentation readiness, regulatory requirements, material availability, and project complexity, but our teams are structured to move quickly once alignment is in place.

Yes, we manage significant seasonal categories including antifungals, nasal health, cold and flu. anti-itch, and sun care. We also maintain the ability to address surge demand through the maintenance of additional production capacity across all of our production lines and facilities.

Yes. Formulated Solutions supports small-scale feasibility batches to enable early concept testing, texture and elegance evaluation, performance assessment, and informed decision-making before committing to full development or scale-up. This approach helps partners reduce risk, accelerate learning, and invest with greater confidence.

Formulated Solutions ensures consistent product quality through a layered, disciplined quality system built on cGMP compliance and operational rigor. Our approach includes cGMP-compliant manufacturing systems, robust batch-to-batch controls and testing, strong data integrity practices supported by validated analytical methods, and strict supplier qualification and oversight.

This is reinforced by an impressive regulatory inspection history across multiple global authorities, reflecting a sustained record of compliance and quality execution.

Backed by more than 25 years of manufacturing experience, our quality systems support OTC, medical device, and emerging prescription (Rx) programs with reliability, consistency, and regulatory confidence.

Formulated Solutions has more than two decades of experience partnering with leading global consumer healthcare companies, supporting many of the most recognizable brands in the marketplace. Our work spans high-volume, highly regulated categories including nasal health, antifungals, pain relief, skin health, wound care, and hygiene, where consistency, compliance, and supply continuity are critical.

We routinely support large global brands through:

Long-term commercial manufacturing relationships spanning multiple product lifecycles

Dual-site production strategies to ensure supply resilience and risk mitigation

Seasonal surge planning for categories with significant demand variability

Technology transfers, line expansions, and packaging or delivery system upgrades

Ongoing product optimization to improve performance, manufacturability, or cost

These partnerships reflect our ability to operate at scale, integrate seamlessly into complex global supply chains, and meet the rigorous quality, regulatory, and service expectations of multinational brand owners.

Yes. Formulated Solutions provides comprehensive label review and documentation support to help with regulatory compliance and a smooth path to market. Our services include label claim compliance assessments, ingredient and formulation reviews, regulatory documentation support, and the preparation of technical justification packages to support product claims, formulation decisions, and regulatory submissions.

Yes. Formulated Solutions supports non-sterile prescription topical, nasal, and oral liquid products across the full development lifecycle, including early-phase clinical trials, clinical feasibility studies, bridging batches, and full commercial supply, where appropriate.

No. Formulated Solutions does not outsource core manufacturing operations. All formulation, blending, filling, and primary packaging activities are performed in-house at our U.S. manufacturing facilities. In addition, we maintain in-house capabilities for incoming raw material and component inspection and verification, microbiological testing, and full analytical release. Qualified external laboratories or partners are engaged only when specialized testing is required, ensuring quality, compliance, and control remain fully within our organization.

Yes. Formulated Solutions welcomes and encourages customer visits to both of our U.S. manufacturing facilities. We regularly host development reviews, quality and regulatory audits, pre-approval meetings, and commercialization workshops, providing partners with direct access to our teams, processes, and capabilities.

Formulated Solutions treats all proprietary information and intellectual property with strict confidentiality. Intellectual property developed specifically for a customer’s product may be assigned, co-owned, or retained based on the agreed program structure, contractual terms, and development approach. This flexibility allows us to align IP ownership with each partner’s strategic and commercial objectives.