Cosmetics

The process of registering a new cosmetic ingredient isn’t simple. The FDA requires an INCI number, but assessment of a dossier containing physicochemical properties, preclinical and clinical data is recommended. In Europe, the applicable REACH and CLP regulations must be met, and the product must be listed on the Inventory of Cosmetic Ingredients. A complete dossier is also mandatory, but animal experimentation is forbidden.
Directive 1223/2009 applies to cosmetic formulations submitted in Europe.This regulation states that the expiry date, tolerability, microbiological quality and purity must be demonstrated and a toxicology assessment performed. For sunscreen products, the FDA requires a dossier like that for pharmaceutical products and absorption studies must be provided for some ingredients.
To sum up, in recent years the authorities have tightened controls on cosmetic products and stricter requirements must now be met.

CMC

Chemistry, manufacturing and control analytical services are conducted under GMP compliance. During development, some phases may be executed according to GLP at the Client's request.

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We have extensive experience performing analytical tests for APIsexcipientsintermediate productsfinished productspackaging materials and process environment samples. The most suitable method is used, according to customer specifications or the relevant Pharmacopoeias description (EP, USP, BP, JP). If non-compendial methods need to be used, we develop and validate the method from scratch or transfer the method from the manufacturer.

We have a comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary methods for excipients, APIs, intermediate products and finished products, according to the ICH Q2 (R1) in line with Q6A and Q6B. Our methods are ready for transfer to contract-giver, in compliance with EU-GMP chapter 6, performing a comparative test, a co-validation in two sites or a revalidation.

We provide full CH studies and on-going stability programmes for third parties. These services, at the client's request, can include: method transfer, method improvement, analytical standards management, storage at different conditions, scheduling of analytical timepoints, full analysis and out-of-trend (OOT) and out-of-specification (OOS) management. These tasks are always conducted according to procedures agreed upon with the client.

We provide microbiological testing for nutraceutical and cosmetic products. Our fully equipped laboratory includes a cleanroom with airlock technology and HEPA filters for the most sensitive operations. ISO methods are implemented and validated iat Kymos laboratories in order to provide quality control services for nutraceutical and cosmetics as quickly as possible.

Cleaning validation is a significant GMP activity to prevent contamination of biopharmaceutical products by ensuring that the processing equipment is suitable for later manufacturing processes. Potential contaminants include residues of the active pharmaceutical ingredients or their related substances, and residues from the products used during the cleaning process such as solvents or detergents. This is particularly important for highly-sensitizing compounds such as antibiotics, hormones and cytotoxics and in the case of parenteral drug products.

Bioanalysis

Chemistry, manufacturing and control analytical services are conducted under GMP compliance. During development, some phases may be executed according to GLP at the Client's request.

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We offer you our experience in studies on Percutaneous Absorption for topical semisolid drug products using vertical diffusion cells (or Franz cells) according to the EMA Draft Guideline on Quality and equivalence of topical products. Both In Vitro Release Test and In Vitro Permeation Test are available using the Hanson difussion Phoenix instrument.