Cosmetovigilance & cosmetic product safety

 

The EU Regulation on cosmetic products (1223/2009) applies in full since 11 July 2013 and completly replaces the Cosmetics Directive (76/768/EEC). 

The Regulation introduces new requirements related to cosmetic product safety as well as new registration procedures.

 

Our cosmetic product safety services include:

 

• Review of your current system and procedures and suggestion  

   of necessary actions to comply with the new Regulation.


• Providing a compliant cosmetics products system, including:

  • Responsible person (RP)

  • Registration of the products in cosmetic products notification portal (CPNP)

  • Preparation and maintenance of product information file (PIF)/

cosmetic product dossier within a web-based solution

  • Set-up of a complete post-marketing surveillance system of

serious undesirable effects (SUEs)

  • Reporting SUEs to the Competent

  • Authorities (CAs)

  • Cosmetic products safety assessment (Safety Report)

  • Preparation and maintenance of consumer information and

product

  • Labelling

  • Training and workshops

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.

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Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
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Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
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Clinical trial safety
Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
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Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
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Quality Management System
Web-based quality management system software including training and document management
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Audits & other support
Includes among others: ad hoc assistance, audits, training, assessment of risk-benefit, medical and scientific writing services
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Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
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Cosmetovigilance
Full range of cosmetic product safety services for all different types of cosmetic products
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Good Distribution Practice (GDP)
Lindeq provides GDP active substances quality system including web based QMS software (ItQMS)