Your Global Partner in Regulatory Excellence
We offer our clients technical support in preparing suitable documentation for cosmetic products. A Product Information File (PIF) is prepared in accordance with applicable European standards, pursuant to Regulation (EC) No 1223/2009 and other applicable legislation.
We offer services that include:
Responsible person
KMJ pharma® Sp. z o.o., as one of the first companies in Europe, offered its clients the opportunity to fulfil the duties of the so-called “RP” (Person Responsible)”, ensuring and thus confirming the compliance of products with requirements in Articles 3, 8, 10,11, 12, 13, 14, 15, 16, 17, 18, 19 sections 1, 2 and 5, and Articles 20, 21, 23 and 24 of Regulation EC No 1223/2009.
In accordance with the applicable law, in the EU it is possible to market only the cosmetic products for which the “person responsible”, which is a legal or natural person, has been appointed in the Community. This person guarantees that appropriate legal obligations will be fulfilled by each marketed cosmetic product, and is a guarantee of the safe use of these products. In accordance with Article 4 of the aforesaid regulation, the producer can appoint any person/entity (based in the European Community) to perform this function, including KMJ pharma® Sp. z o.o.
KMJ pharma® Sp. z o. o. will help you ensure full compliance of products with the applicable legal requirements and exercise supervision of safety and quality of your products by cyclical product reviews, reporting undesirable effects and audits regarding the compliance of products dossiers.
Clinical & Quality testing
Our range of services includes both basic and advanced types of cosmetics tests, including:
- microbiological tests
- dermatological patch tests
- dermatological patch tests + hypoallergenicity tests
- dermatological application tests
- dermatological application tests under the direction of an additional specialist
- laboratory tests
- dermatological application tests + laboratory tests
- challenge tests
- SPF
- waterproofness testing
- phototoxicity and photoallergy testing
- photostability testing