Concept + claim map
Consumer, channel, intended use, product format, benchmark, and claim ambition
OTC Product Development + Manufacturing Partnership
Your OTC concept.
Built for real life.
Bring us the consumer need, product vision, and claim ambition. We help connect the regulatory pathway, formulation, testing, packaging, manufacturing, and launch requirements needed to turn the idea into a qualified commercial program.
FORMULA / ACTIVE / CLAIMCOSMETIC→OTC
Starting MOQ5,000+units / starting commercial program quantity
01 / How we help
One connected
OTC program.
You bring the idea. We help build the route from product brief to qualified commercial production.
OTC development works best when formulation, regulatory strategy, testing, packaging, quality, and manufacturing are planned together from the beginning. Our role is to help your team see the complete path, make the right decisions in the right order, and avoid building a beautiful product around an unsupported claim or unsuitable active system.
Support is modular. We can help evaluate an early concept, develop a custom formula, strengthen an existing formula, coordinate the agreed testing and label pathway, source packaging, or assemble a broader development-to-manufacturing program.
Regulatory feasibility
Classification, current monograph or other pathway, active, dosage form, and risk review
Formulation R&D
Technical brief, raw-material strategy, prototypes, feedback, and formula refinement
Testing + evidence
Stability, compatibility, performance, quality, and category-specific study planning
Label + packaging
Drug Facts architecture, claims, required statements, component sourcing, and compatibility
Manufacturing + quality
Qualified scale-up, controlled records, production, release, and lifecycle responsibilities
02 / Product classification
A product can be
a cosmetic and a drug.
Classification follows intended use, not visual style or the aisle where a product is sold. We establish the intended use and claim boundary first, then map the current OTC monograph or other applicable pathway before formula development begins. A formula intended only to cleanse, beautify, or moisturize is generally cosmetic. Add a therapeutic or disease-prevention claim and the product may also become a drug.
Describes appearance, cleansing, conditioning, or beautifying without a therapeutic claim.
Adds a regulated drug use supported by the applicable sunscreen conditions and required testing.
The same finished product must satisfy the requirements that apply to both cosmetics and drugs.
03 / Product opportunity map
SPF and sanitizer
are the beginning.
They are two clear examples, not the limit of the conversation. Bring us the consumer problem and desired use; we will evaluate the regulatory route, formula, evidence, facility fit, and commercial pathway.02current development priorities
04additional families to evaluate
01connected qualification pathway
01Current development focus
Sun care + SPF
Sunscreen lotions, creams, sticks, and cosmetic-drug hybrids such as daily moisturizers with SPF.
Active system · SPF / Broad Spectrum testing · water-resistance pathway · Drug Facts02Current development focus
Consumer hand sanitizer
Gel and liquid consumer antiseptic-rub concepts designed around an eligible active system and intended use.
Active strength · sensory profile · directions and warnings · package compatibility03Evaluate with us
Acne + skin protection
Acne-care and skin-protectant concepts where the therapeutic purpose, dosage form, active, and cosmetic experience must be designed together.
Current monograph · claim boundary · testing · facility and format fit04Evaluate with us
Scalp + hair care
Anti-dandruff shampoo and scalp-care concepts that can carry both cosmetic cleansing benefits and an OTC drug purpose.
Active compatibility · shampoo performance · Drug Facts · claim review05Evaluate with us
Oral care
Anticavity toothpaste and gel concepts where active delivery, flavor, foam, texture, packaging, and labeling must work as one system.
Active and dosage-form fit · testing · label architecture · manufacturing qualification06Bring us the use case
Additional OTC concepts
Antiperspirant-deodorant, topical analgesic, and other nonprescription product ideas can enter a structured feasibility review.
No category is assumed: pathway, evidence, facility scope, and commercial fit are confirmed firstBuilding the right pathway
Every OTC concept brings its own intended use, active system, dosage form, claims, packaging, and commercial goals. Our team evaluates these elements together and develops a qualified pathway for formulation, evidence, manufacturing, timing, and minimums. This gives your product a clear and practical route from opportunity to commercial production.
Inquire now ↗︎04 / Two claim examples
See how a claim
changes the work.
SPF and hand sanitizer show the principle: a monograph does not create unlimited claims. It creates a defined communication boundary, and the formula, testing, labeling, and marketing must tell the same regulatory story.
SPF / SunscreenClaim examples
Core sunscreen use. Additional claims depend on Broad Spectrum status, SPF value, test results, directions, and the current monograph.
When the required tests and directions are satisfied, labeling may include the qualified skin-cancer and early-skin-aging risk-reduction statement described by FDA.
The duration must be supported by the applicable water-resistance test. “Waterproof,” “sweatproof,” and “sunblock” overstate performance and are not acceptable sunscreen claims.
Hand sanitizerClaim examples
Claim language must be matched to the applicable consumer antiseptic-rub conditions, active system, Drug Facts, and directions.
A sanitizer should not be positioned simultaneously as a rinse-off wash, first-aid antiseptic, healthcare antiseptic, surface disinfectant, or food-use product unless the applicable pathway supports that use.
Claims such as preventing specific diseases, killing named viruses, providing extended protection, or “sterilizing” can exceed the applicable OTC conditions and may require a different evidentiary or approval pathway.
Examples are educational, not pre-approved label copy. Every claim must be confirmed against the current product facts, testing, applicable FDA conditions, and complete label.
05 / Your project journey
From your brief
to a commercial run.
- 01Consumer + commercial brief
Discover
We translate your audience, channel, benchmark, target experience, launch timing, and business goals into a technical starting point.
- 02Intended use + claim boundary
Classify
We examine what the product is intended to do and say, then determine whether it is a cosmetic, an OTC drug, both, or requires another pathway.
- 03Monograph + feasibility plan
Scope
We map the current regulatory conditions, active options, dosage form, testing, documentation, facility fit, expected investment, and decision gates before development moves forward.
- 04Active + product experience
Formulate
Our R&D team develops the active and inactive system together so performance, aesthetics, stability, packaging, and consumer use work as one product.
- 05Pilot samples + feedback
Refine
We make laboratory or pilot samples, collect focused feedback, and refine the formula against the agreed technical brief and regulatory boundary.
- 06Stability + required testing
Prove
We define and coordinate the appropriate performance, stability, compatibility, quality, and category-specific evidence for the formula and proposed claims.
- 07Drug Facts + packaging
Prepare
We help align the principal display panel, Drug Facts, warnings, directions, ingredient presentation, claim language, and packaging system with the qualified product.
- 08Manufacturing + release
Produce
After technical and regulatory qualification, we confirm the manufacturing route, batch documentation, quality controls, release criteria, supply plan, and commercial quantity.
- 09Launch + lifecycle
Support
We coordinate the agreed registration, listing, record, change-control, complaint, and ongoing product-stewardship responsibilities around launch.
5,000+units / starting commercial program quantity
06 / Why the minimum is higher
OTC scale carries
more than product.
OTC programs require a deeper operating package than conventional cosmetics: active-material qualification, controlled documentation, category-specific testing, packaging compatibility, compliant Drug Facts, line and batch controls, release criteria, and regulatory records. The starting quantity reflects the technical and operational system required to bring the program together responsibly.
Qualification noteFinal minimum may be higher based on active system, test plan, formula, package, batch scale, supply constraints, documentation, and qualified manufacturing pathway.07 / Regulatory source desk
Follow the current
FDA framework.
OTC requirements can change through administrative orders, legislation, guidance, and enforcement. Final project decisions use the current source—not a static website summary.Tell us the consumer need, channel, claim ambition, and launch target.