For almost a decade, RNA has offered FDA-approved OTC formulations for topical products such as antiperspirants, dandruff shampoos, pain creams, and skin treatments.
OTC means Over the Counter, and is a known term that identifies products that have FDA approved actives and are made with the FDA's monograph of that active. Not every manufacturer is able to make OTC formulations - RNA has been formulating and making FDA OTC products for over a decade. We handle all the work from formulating, manufacturing, testing, and getting your products registered with the FDA. We've done this for many brands and hundreds of products and have the expertise required to be compliant.
In addition to our library of several thousand formula, we also have an entire subset of OTC formulations. Our in-house analytical lab can handle OTC testing to ensure compliance for our products, while our team of regulatory experts coordinates FDA testing for batch validation and active ingredient testing for our formulations. RNA can manufacture a product that delivers results and won't run into compliance roadblocks.
Our team has extensive knowledge of raw materials and their properties, allowing us to create effective and safe products for a variety of indications. We also have access to state-of-the-art manufacturing equipment, which enables us to produce high-quality products at scale. In addition, we have established quality control measures in place to ensure the consistency and efficacy of our final products. This includes strict testing protocols and a commitment to using only the highest quality raw materials.
To become an FDA registered company, a business must first complete the registration process with the U.S. Food and Drug Administration (FDA). This process involves providing the FDA with information about the company's facilities, processes, and products. In order to register with the FDA, a company must have at least one "establishment" that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device. This establishment must be located within the United States or its territories.
The FDA requires that companies submit a registration form and pay a fee for each establishment. The registration form must include the name and address of the establishment, as well as the name and title of the individual responsible for the establishment's compliance with FDA regulations.
In addition to registering with the FDA, a company must also comply with all relevant FDA regulations and guidelines. This includes following Good Manufacturing Practices (GMPs) for the production of drugs and devices, as well as obtaining premarket approval or clearance for certain products.
Overall, becoming an FDA registered company requires a thorough understanding of FDA regulations and a commitment to compliance. It is a crucial step for companies looking to manufacture and sell products in the U.S. healthcare market.
ISO 9001 and ISO 22716 are internationally recognized standards that outline requirements for quality management systems and good manufacturing practices (GMPs) in the cosmetics and personal care industry, respectively. Achieving compliance with these standards can be beneficial for companies looking to demonstrate their commitment to quality and consistency in the production of their products.
To become ISO 9001 compliant, a company must implement a quality management system (QMS) that meets the requirements outlined in the ISO 9001 standard. This includes establishing clear policies and procedures for processes such as product development, production, and customer service. The QMS must also be documented and regularly reviewed and updated to ensure its ongoing effectiveness.
To become ISO 22716 compliant, a company must implement GMPs that meet the requirements outlined in the ISO 22716 standard. This includes establishing clear policies and procedures for processes such as facility design, personnel training, equipment maintenance, and product testing. The GMPs must also be documented and regularly reviewed and updated to ensure their ongoing effectiveness.
In order to become compliant with ISO 9001 and ISO 22716, a company must undergo a certification process, which includes a thorough assessment of the company's QMS and GMPs by a third-party certification body. Once certified, a company must maintain compliance with the standards through regular audits and reviews to ensure that their QMS and GMPs are up-to-date and effective.
Overall, achieving compliance with ISO 9001 and ISO 22716 requires a commitment to quality and a thorough understanding of the requirements outlined in these standards. It can be a valuable step for companies looking to demonstrate their dedication to producing high-quality products.
In conclusion, RNA is a trusted and reliable partner for the formulation and manufacturing of OTC topical drug and personal care products. Our team has a deep understanding of raw materials and their properties, as well as access to state-of-the-art manufacturing equipment. We have established quality control measures in place to ensure the consistency and efficacy of our final products, and are committed to providing exceptional customer service and support throughout the development and manufacturing process.
In addition, RNA has demonstrated its commitment to quality by becoming FDA registered and compliant with ISO 9001 and ISO 22716. These accomplishments demonstrate our dedication to meeting the highest standards for quality management and good manufacturing practices.