INCOSPHAR
Founded in 2014 and located in Porto, ICP (Incosphar Consulting Services) offers its clients a combined Scientific, Regulatory, Legal and Project Management expertise in the field of Cosmetics, Medical Devices, Biocides and Food Supplements.
ICP has a long experience of providing consultancy services, combining a multidisciplinary team with unparalleled technical expertise consultants that worked for industry. Our team has a long experience across all areas of personal care industry, including development, distribution and manufacturing. ICP brings professionalism, convenience and efficiency to companies that wish to evaluate partially or totally ingredients, mixtures or finished products for manufacture or marketing.
Improving the protection of human health was one of the key drivers that leads the European Union to recast the Cosmetic Directive as regulation, which in turn further increased the data aspects needed to place personal care products onto the European market. In cosmetic industry the regulation field is extremely important and frequently complex. The regulatory requirements in this sector are vast and frequently updated, requiring the adaptation of processes and documentation in areas that require compliance. Although some companies dispose of Regulatory Department, many others need outside help to meet this need. Thus, the ICP aims to provide a legal monitoring service, with the advantage of being able to complete the studies required by law.
If you are based in the European Union or looking to import from outside the European Union, we will help you address compliance with all relevant regulations.
If you would like to know more about ICP personal care capabilities or further information on how we can help please contact us.
We offer a wide variety of services to achieve the best results
COSMETICS
– Product Information File (PIF) Elaboration
– Safety Report Elaboration
– Responsible Person
– Notification of Cosmetic Products on Cosmetic Products Notification Portal (CPNP)
– Labeling Translation and Review
– Importation Support
– Development of Cosmetic Formulations
– Improvement of Cosmetic Formulations
– Stability Studies
– Search of Active Ingredients
– INCOSPHAR provides testing in accordance with EURL ECVAM (the European Union Reference Laboratory for Alternatives to Animal Testing) validated protocols to analyze ingredients or cosmetic formulations with in vitro skin models based on human reconstructed epidermis for irritation, corrosion and surface adhesion studies. These studies can help predict the cytotoxic effect of the chemical or personal care product.
# Citotoxicity against different skin cell lines
# Skin irritation test (OECD 439)
# Skin corrosion test (OECD 431)
# Permeability studies with Franz cells (OECD 438)
– Training formation on work regarding cosmetic products and scientific studies carried out
– Marketing material of final product for consumers presentation
– Preparation of presentations and posters in order to communicate results to the scientific community.
– Technical translation of marketing material
– Development of internal audits with an expert team for companies certification
BIOCIDES
In September 2013, the new Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) came into force. This regulation requires a more stringent analysis of biocides than previously. We smooth the registry process at the Competent Authority, enabling a prompt market placement. Our services included:
– Biocidal active substance dossiers for EU approval (Dir. 98/8/EC, Reg. (EU) 528/2012)
– Biocidal product dossiers for national / EU authorisation (Dir. 98/8/EC, Reg. (EU) 528/2012)
– Preliminary or stand-alone risk assessments
– Expert statements
– Literature research
FOOD
SUPLEMENTS
Food supplements are considered food with some specificities, such as dose form , and are intended to complement or supplement a normal diet.
In accordance with the regulatory framework, our team could help you with:
– Technical Dossier Elaboration;
– Verification, revision and labeling translation.
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