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Hello,
I am Dr.M, an OTC specialist at OTCM.
At the "Global K-Beauty Conference 2026" hosted by Maeil Business Newspaper on June
16, our CEO, Sung-ho Lee, delivered a presentation titled "The Core of Entering the
US Market : Everything About OTC Cosmetics Development." It sparked immense
interest from numerous brand representatives.
To share these valuable insights with more of our clients, we are adapting the
presentation into a three-part newsletter series. Today, in our second installment,
we reveal the secret behind how OTCM accelerates the commercialization of US OTC
products to just 4 months through our unique parallel development process and
regulatory expertise.
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point 1
Accelerating Time-to-Market :
The Parallel Development
Process
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The single biggest differentiator of OTCM is our parallel development process,
where multiple development stages run concurrently.
Generally, manufacturers follow a sequential approach to minimize risks.
However, leveraging our extensive library of formulation data and proven OTC
development expertise, OTCM runs these phases in parallel, drastically shortening
the development timeline.
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Formulation Development
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We don't start every project from scratch. By utilizing our pre-validated OTC
formulation library, we optimize fragrances and active marketing ingredients
to finalize formulas in the shortest time possible.
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Clinical Testing |
Conducted Concurrently with Formulation Development
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Clinical trials begin the moment the formulation is locked in. Because OTCM operates
a
specialized clinical institution as a subsidiary, we manage the entire schedule
directly without any waiting periods associated with external agencies.
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Stability Testing |
Executed in Parallel with the Development Phase
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OTC products require stability evaluations conducted under environments that
replicate actual production conditions. With production infrastructure spanning
from pilot-scale to commercial-scale facilities, OTCM performs testing and
mass-production preparation simultaneously.
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point 2
Overcoming the Hidden Hurdle of OTC Projects :
Regulatory Documentation
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Project completion does not end with product development.
Once accelerated stability data is secured, a massive volume of manufacturing
documentation and Process Validation (PV) must follow. In reality, many companies
spend far more time and capital at this stage than during the actual product
development phase.
Supported by the quality management systems and regulatory know-how inherited
from our parent company’s API (Active Pharmaceutical Ingredient) manufacturing
business, OTCM provides systematic assistance throughout this entire process.
In particular, our extensive experience in document control and quality system
operations—honed by supplying raw materials to global top-tier clients—is
seamlessly integrated into OTCM’s manufacturing workflows.
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point 3
OTC-Dedicated Production Infrastructure Engineered for FDA
Standards
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In the US market, the manufacturing environment itself is evaluated just as
critically as the product.
From its inception, OTCM designed and built a smart-factory-based finished
product manufacturing facility with OTC production in mind. We have strictly
segregated our weighing, manufacturing, and storage zones to prevent cross-
contamination and minimize any risk of raw material mix-ups.
This advanced
design
serves as a powerful advantage not only for OTC products but also for
Halal-certified manufacturing.
"Entering the US OTC market is not just about manufacturing a sunscreen.
It is a highly complex project where development, clinical trials, regulations,
production, and document control must function as a single, unified system.
By bridging our parent company’s API manufacturing capabilities, FDA regulatory
experience, and dedicated OTC infrastructure, OTCM empowers brands to
penetrate the US market faster and more efficiently."
In next week’s final installment, [Part 3: FAQ], we will break down the most
frequently asked questions and crucial answers that brands encounter during actual
meetings when preparing to enter the US OTC market. Stay tuned!
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OTCM, Korea's First True OTC Specialist.
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Next week, in the final installment of the series, Part 3: FAQ, we will introduce
the key issues most frequently raised by brands preparing to enter the U.S. OTC
market during actual meetings, along with practical solutions.
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