What is Eviderm Institute?

Eviderm Institute is a knowledge-based company focusing on scientific coaching of product development and quality assurance in cosmetics, topical pharmaceuticals and medical device. Clinical testing, research, documentation and regulatory advice belong to the core areas. We create opportunities to our customers. 

The name Eviderm reflects clearly evident results. 

We achieve successful recipes for the skin using evidence, transparency and creativity. The company was founded 2009 by Marie Lodén.

Services

RESEARCH AND DEVELOPMENT

  • Development of tailored research and clinical trial programmes, especially within skin barrier function, penetration and eczema. Bioengineering measurements. See CV and Publication list. 
  • In-house efficacy/safety testing or placement and follow-up of clinical studies on patients or healthy volunteers.
  • Adaptation of the Cosmetic Product Information File for EU, Asia and Russia.
  • Expert advice on ingredients and formulations with respect to efficacy, safety, environmental and consumer/media opinions.
  • Ethical committees and regulatory authority applications.
  • Safety assessments, pharmacological-toxicological, clinical and other expert reports for internal use or submission to medicinal authorities or notified bodies.
  • Cosmetic product safety assessment in accordance with new cosmetic regulation. See Certificate of Qualifications.
  • Compilation of Product Information File (Cosmetic dossier) in accordance with new EU cosmetic regulation. Read more

EDUCATION & COMMUNICATIONS SUPPORT

  • Training: Education and implementation of new processes. E.g. to comply with the new cosmetic regulation.
  • Medical writing: Conversion and formatting of scientific study data into manuscripts suitable for publication in peer-reviewed journals.  Eviderm ensures document content and that style adheres to submission guidelines. Eviderm also reviews content of draft and final documents prepared by other writers before external distribution
  • Promotion and Media: Translation of scientific research into consumer language without losing the evidence and scientific integrity. Eviderm strengthens the link between advertising claims and product reality. For example, read more about the EU Common Criteria.

MANUFACTURING

  •  Identification of contract manufacturers, audit, technology transfer and outsourcing.

QUALITY

  • Act as an Authorized Representative for Mediical Device and as Responsible Person for imported Cosmetics (see checklist below).
  • Qualified Person,  quality management, market surveillance, pharmacovigilance.

Proposed Due Diligence Checklist of imported cosmetic products.

Labelling and registration

  • Appropriate information given on the container (e.g. address, usage information, ingredient listing in accordance to EU, batch number, expiry date/PAO, manufacturing country)
  • Ingredient List - No unlabelled additives present in raw materials?
  • Ingredient List - Fragrance allergens labeled properly?
  • Cosmetic Products Notification Portal (CPNP) ok?
  • Appropriate wording of conditions of use and warnings, if applicable?

 Formula: Ingredients / composition

  • Restricted ingredients within approved use levels? Absence of banned ingredients?
  • No banned combination of ingredients? (e.g. to prevent formation of nitrosoamines)
  • Raw material documentation: physical and chemical characteristics, impurities, traces, additives as applicable.
  • Raw materials specifications show appropriate purity?
  • No animal testing performed after the step-wise implementation of the ban?
  • Nanoparticles? Assessed and labeled properly?
  • Origin of raw material? Animal derived? If yes, necessary documentation.
  • IFRA for fragrances/flavors

Stability, efficacy and safety substantiation

  • Physical stability tests available and ok?
  • Any chemical instability which can induce safety problems and labeling requirements? (e.g. formaldehyde release, nitrosoamines)
  • Preservation efficacy test ok?
  • Proper container and no banned ingredients? (e.g. phthalate softeners in PVC?)
  • Product specification available? Microtesting at release fulfill regulatory requirement?
  • Evidence to support claims? E.g. SPF testing in accordance with EU recommendation. Other claims.
  • Safety assessment made? Copies of any safety testing done on the product.

Others

  • Good Manufacturing Practice corresponding to ISO 22716?
  • Quality and other contractual agreements in place? Responsible Person identified? Traceability of the supply chain?
  • System for reporting of serious adverse events in place?
  • Manufacturing Method
  • Description of Batch Coding
  • REACH registration

Address:
Eviderm Institute AB
Bergshamra Allé 9,
SE-17077 Solna, Sweden.
Phone: +46-708285832

Importing cosmetics into EU? Checklist Responsible Person.

Benefits

Evidence based and state-of-the-art services provide an expedient, cost-effective development of topical products (e.g. cosmetics, pharmaceuticals, medical device).

Affiliation with a broad network of scientific and regulatory experts, manufacturers and testing laboratories that can be coordinated to provide complete client support.

Individual attention, technical expertise and efficiency designed to accommodate tight schedules for new development.

Contact Eviderm:

Eviderm Institute är ett konsultföretag som utvecklar produkter och skapar information om produkter för huden som kosmetika, hudläkemedel och medicinteknik. Vi finns i Solna.
Postadress: Bergshamra Allé 9, 17077 Solna. Besöksadress: Bockholmsvägen 1 (T-bana Bergshamra, södra uppgången, buss 503, 540).
E-post: marie.loden@eviderm.se Mobil: 0708285832
Org.nr. 556787-6908.
© 2009 Allt material på denna webbsida är skyddat enligt lagen om upphovsrätt.