Regulatory

E-Pharma Trento provides regulatory support and documents for the registration of pharmaceutical and food supplement products developed and/or manufactured at our premises. The Regulatory support is available during the pre-approval and post-approval phases of the product covering the whole product’s lifecycle.

Documentation

Pharmaceutical Products

- dossier in CTD format, in accordance with  Notice to Applicants – volume 2B

- dossier in e-CTD format available if requested

- declarations: TSE, GMO, GMP

- CPP for applications in extra EU Countries

- documents of API manufacturers

 

Our Regulatory Affairs department collaborates with experts for the redaction of the clinical modules. 

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



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 components

 

Certifications

- EU GMP Certificate issued by the Italian Medicines Agency (AIFA)

- Authorization/recognition issued by the Italian Health Authorities to produce pharmaceuticals and food supplements

- E-Pharma has been succesfully inspected and is registered by the FDA website as manufacturer of food supplements for the US market

- E-Pharma is registered by the TGA for the Australian market

- E-Pharma is registered by the United Arab Emirates for the market of food supplements

 

E-Pharma Trento SpA can provide legalized documents on request.

 

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