A-pharmaconsult Cosmetics Regulatory Services

As a specialist in consultancy services, the A-pharmaconsult offer includes acting as a Regulatory Affairs partner, helping cosmetics companies ensure standards compliance and bring products to market.

A-pharmaconsult Regulatory services in the cosmetics field include writing of product Information files for safety, efficacy and manufacturing, product positioning and strategies for EU and export markets, product development assistance, and regulatory intelligence., including Safety reports (Part A & B).

Cosmetics expertise

A-pharmaconsult provides a full range of consulting services for the development and notification of Cosmetics in Europe. Detailed services provided include:

• Expertise in product evaluation: this includes detailed advice on all the various tests that a cosmetics product must pass in order to comply with international regulatory guidelines and confirm they do not pose any risk to human health and whose results must form part of the final product dossier. These tests include:
  • Stability Studies that measure the products against effects of aging, transport and prolonged storage, as well as challenge testing against possible contamination by various germs and bacteria
  • Safety Studies for risks such as ocular tolerance, skin tolerance, etc.,
  • Product Efficacy Studies to prove effectiveness of a cosmetic product for all its claims, including laboratory ex-vivo skin testing, clinical or instrumental testing,
• Writing of product labelling: this is a further area of specialized expertise with all cosmetic and personal care product labelling required to follow detailed specifications and parameters, including ingredients lists that align with INCI (International Nomenclature for Cosmetic Ingredients) in the EU or UK Cosmetics Regulations. (EC) No. 1223/2009 (UKCR).
• Evaluation of promotional material: All promotional and marketing material must comply with such standards as those defined under the Cosmetic Products Regulation (EC) No 1223/2009 and Commission Regulation (EU) No 655/2013 on Common Criteria for Claims that impose specific requirements for cosmetic products claims that must conform to Common Criteria and be legally compliant, truthful, supported by evidence, honest, fair and allow informed decision-making by consumers. Other relevant regulations include the EC Medicinal Products Directive 2001/83/EC, Biocidal Products Regulation 528/2012 Cosmetic Products Directive 76/768 and the Medicinal Products Directive 2001/83, as well as UK regulations such as Cosmetic Product Enforcement Regulations 2013 (2013 SI No 1478) and Consumer Protection from Unfair Trading Regulations 2008 (2008 SI No 1277).
• Writing of dossiers for Cosmetics: A-pharmaconsult can help clients prepare complete product information file (PIF), including safety reports, according to EU current regulations.
• Notification to the Authorities: Once all product evaluation is complete, A-pharmaconsult can assist clients in finalizing the cosmetic dossier, ready for notification with relevant authorities, such as the EU CPNP (Cosmetic Products Notification Portal) mechanism for the registration of cosmetic products. This will include designation of a Responsible Person, ensuring all mandatory data is present and correctly formatted, timely adjustment in case of product changes and variations submitted for your products, is maintained and timely adjusted (e.g. in case of product updates such as reformulation or label updates).

Resources

Click on A-pharmaconsult Regulatory Affairs Services  for further information.