Regulis devises regulatory strategy for a cosmetic that results in increased cosmetic and medicinal product sales in dermatology sector for leading OTC/generic company.
A company wanted to increase public awareness of their dermatology medicine but was unable to do so because cosmetics regulations did not permit promoting of the product to the public.
The company approached Regulis to ask if they could help them meet the regulatory requirements to put a cosmetic on the market. As a cosmetic, the product would not fall under medicines regulation, meaning it could be sampled and marketed directly to consumers. The downside of this approach was that the sales of the medicinal product would be eroded.
Using our knowledge of cosmetics and medicines regulation, and no small amount of creative, commercial thinking, Regulis developed an innovative regulatory strategy not only to get a cosmetic cream to market as quickly as possible, but also to maintain an existing medicinal product marketing authorisation.
- The clever part of this plan was that both products had the same formulation, differing only in the labelled uses and claims, so product development costs were kept incredibly low.
- Regulis used its expert knowledge in regulatory affairs to prepare a safety assessment and labelling to comply with the cosmetic regulations.
This allowed the company to give product samples of the cosmetic product to customers (end users), completely in accordance with UK cosmetics regulations, whilst increasing awareness of both the cosmetic and medicinal products. This had a significant commercial upside, creating greater demand for and delivering increased sales of both the cosmetic and the medicine.
The Regulis engagement delivered:
- Minimal development costs
- The opportunity for the company to promote their product directly to the public
- Increased awareness of both the cosmetic and medicinal product
- A significant commercial upside, creating greater demand for and delivering increased sales of the products.
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