Medicinal products for human use

  • Preparation/submission/follow-up of marketing authorisation (NP, MRP, DCP, CP)
  • Modification of MA (renewals, variations, MAH transfers)
  • Preparation, translation and revision of texts for SPC, PIL and Labelling
  • Consulting 
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Cosmetics

  • Registration (COSMET-AEMPS)
  • Product Information File (PIF)
  • Responsible personon
  • Notification CPNP

  • Labelling and packaging reviews

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Medical Devices

  • Registration (AEMPS-PMPS)
  • Compilation of Technical Documentation
  • CE-marking
  • European Representative

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Clinical trials

  • Narrative writing
  • Writing clinical study reports
  • Preparation/Submission the application to the Spanish Authorities 
  • Communication with regulatory bodies to obtain clinical trial authorisation

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Medicinal products for veterinary use

  • Notifications RAEVET-AEMPS
  • Modification of MA (variations and renewals, transfers)
  • SPCs, labels and leaflets.
  • Communication with HA

 

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Herbal products

  • Preparation of SmPC, PIL and labelling
  • Readability User Test. Braille
  • Wholesalers Authorisation
  • Manufacturer and Importer Authorisations
  • Qualified Person

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Food Supplements

  • Registration
  • Preparation of technical dossier
  • Labeling preparation/analysis
  • Notification to Health Authorities
  • Certification of food products
  • Communication with Health Authorities

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CONTACT US

If you are interested in working with Revipharm, either through collaboration or by contracting us to work for you, please contact us. We would be happy to further discuss your needs and provide you with a free quotation.

 

Email: info@revipharm.es

Tel.: +34 961135444

Fax.: +34 961128365

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