Sensilab Group Polska
Registration

Registration

Departments of Registration and Adverse-Effects, made up of qualified professionals (pharmacists and chemists), are involved in the following activities: • medicinal products (creating of a registration dossier, including eCTD dossier and post-registration documentation) • pharmacovigilance (PSMF development, providing the services of the person responsible for EudraVigilance-QPPV, preparation of the Risk Management Plan RMP, electronic reporting to EMA) • cosmetics (cosmetic dossier preparation, declaration preparation, electronic notification to the European database CPNP) • dietary supplements, foodstuffs for particular nutritional uses (declaration and leaflet development, package graphic-design verification, electronic product notification GIS) • medical devices (electronic reporting and notification of products to URPL, WMiPB) • subject representation infront of the relevant authorities and following-up on the advancement of processes and procedures

Besides medicinal product (drug)-, dietary supplement- and medical device registration services, we also offer pharmaceutical consulting services, in it:

  • advising on and supervising of declarations refering to health claims (dietary supplements, cosmetics, medical devices)
  • technical supervision of prints prescribing information for medicinal and biocidal products
  • registration dossier assessment
  • deciding on the registration/notification procedure
  • registration application accompanied by the necessary product documentation
  • preparation of e-CTD documentation
  • registration process surveillance
  • notification documentation preparation

 

Out-licencing           

In relation to Contractual-Cooperation Sensilab also provides:

  • existing registration documentation for OTC and Rx products
  • new medicinal product composition formulation, technology- and analytical method development in accordance with EU regulations
  • final product manufacture according to GMP standards
  • technology transfer
  • cooperation in the field of distribution/export agreements

Contact

Contract manufacturing services:

 

Export:
Marcin Granat
Export Manager
tel. kom.: 519 134 363
tel.: + 48 22 613 06 52
marcin.granat@sensilab.eu

 

Contract manufacturing services:
Małgorzata Dolžan
Business Development Manager
t: + 48 22 613 06 52
malgorzata.dolzan@sensilab.eu
services@sensilab.com

 

 

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