• Licensing-out
• Project management
• Registration strategy
• eCTD
• Pharmacovigilance
• Marketing and distribution

Licensing-out

Pharma Resources can offer to assume activities in the field of regulatory affairs on behalf of the marketing authorisation holder. These activities include all functions according to German Drug Law (AMG).

• Preparation of European Drug Master File (EDMF) including CEP application
• Preparation of Summary of product Characteristics (SPC), Patient Information Leaflets (PIL) and labelling
• Readability testing of Patient Information Leaflets (PIL)
• Preparation of expert reports
• Updating of registration dossiers including requested translations
• Variation to Marketing Authorisations
• Renewal of Marketing Authorisations

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Project management

If you plan to develop a new generic drug Pharma Resources can consult and assist you to guarantee a successful procedure. This support include as well to select the active pharmaceutical ingredient and to choose the contract manufacturer specialised in various finished dosage forms as the assistance in analytical problems and production processes

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Registration strategy

If you have finalised a registration dossier but do not have the capacity or experience for running a registration procedure Pharma Resources can support you to decide for a registration procedure and can support you in the realisation of national procedure, MRP or DCP including all steps beginning with compilation of application form to granting the approval.

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eCTD

Applicants are advised that, from 1 January 2010 it will be mandatory to use the eCTD format for all electronic submissions.

Pharma Resources can convert your CTD applications and your “old” documentations to eCTD format.

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Pharmacovigilance

Pharma Resources offers a wide range of Pharmacovigilance services.

• Preparation of Periodic Safety Update Reports (PSUR)
• Continuous management of literature researches
• Reporting of adverse reactions
• Takeover of the function Qualified Person

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Marketing and distribution

After granting the approval Pharma Resources can support you to deliver the relevant APIs or the finished dosage forms including batch release and in case of import from non-EU countries including EU batch testing.

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