Custom Formulation

Research & Development

If you have discovered a product you are interested in distributing, you are encouraged to confidentially share your concepts with us. Our formulation and product development services include the creation of creams, lotions, serums, gels, and products of various consistencies. By adding strategic ingredients, we can customize the formulation to make the new product exclusively yours.

We ensure that your product meets all regulatory requirements throughout the development process. When developing or modifying existing formulations classified as OTC drugs, please consider the following timeline and expenses:

Formulation and Creation of R&D Batches

This step covers selecting active and excipient ingredients with proper potencies according to the OTC drug monograph. After approval of all components, we quickly formulate and create R&D batches, making minor adjustments at no extra cost. The container and closure system must also be chosen and tested for potential contaminants. Finally, labels and marketing materials should comply with regulations and be reviewed by a regulatory consultant to ensure FDA labeling requirements are met.

Pre-Market Testing for New Monographed OTC Products

• Formal specifications must be established for raw materials, container components and finished drug products.
• Raw material testing
• Product-specific validation of testing methodologies. This testing helps to determine specificity, linearity, repeatability, placebo effects, and the potential for interference caused by API degradation. These are one-time tests that require significant financial investment. An estimated cost will be provided before the start of any product development project.
• Preparation of small batches for accelerated stability studies to assign expiration dates. Testing must continue for at least six to nine months to assign two to three years of product stability. Additionally, at least one batch per year must undergo a real-time stability study under recommended storage conditions. An estimated cost will be provided before the start of any product development project.
• Process validation to ensure the process equipment and operating parameters are appropriate and helps create a product that meets all specifications and acceptance criteria.
• Owners of OTC drug products must complete and submit a Drug Listing Form to the FDA regarding the product they intend to launch.
• In-process and final quality control (QC) release testing for each batch

Packaging, Artwork, Design & Brand Consulting

If needed, we are happy to provide references for packaging, artwork, and design services.

Abbreviated Lead Times

Recognizing the demands of “just in time” inventory systems, we understand that standard lead times of five to six weeks may not suit every customer. We offer flexible adjustments to facilitate a quick turnaround, provided that all necessary components have been received and approved at our facility.

Small Batch Runs

As a valuable and unique service, Private Label Partners offers small batch runs. This service is beneficial for companies interested in conducting market research within limited market segments or specific geographic areas.