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Regulatory

We provide highly professional and customized regulatory and documental support to our customers for the registration of pharmaceutical and food supplements, developed and/or manufactured at our premises.

 

We follow, together with our customer, the regulatory and the registration process of the product, in compliance with the European Standard documentation, granting our professional and flexible support.

 

We collaborate with renowned experts for the redaction of the clinical modules.

 

Documents are in English and compliant with ICH and EMA guidelines.

 

From the licensing-out to the Marketing Authorization: we can license out our technical documentation for the customer to apply for a MA procedure in its country, but we can also apply directly for a MA in Europe and then transfer it to the customer.

 

Our regulatory support covers the pre-approval and post-approval phases of each product, for its entire lifecycle at E-Pharma. In case of variations to the dossier, we offer a set of documents useful to apply for them to the competent health authority.

 

 

DOCUMENTATION

 

Pharmaceutical Products

  • dossier in CTD format,
  • dossier in e-CTD format available if requested
  • declarations: TSE, GMO, GMP
  • CPP for applications in extra EU Countries
  • documents of API manufacturers

 

Food Supplements

  • product Technical Documentation / Food supplements dossier containing information regarding product composition, manufacturing process, analyses and regulatory information useful for the preparation of the label of the finished product.
  • declarations on food supplements and on its single component.
 

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