pharma projectmanagement
dewepharma is specialized in the registration and marketing authorization of complementary and herbal medicinal products. We divide this process into the 3 column "Project Start", "Project Implementation" and "Market Entry". Within these columns, we offer various consultations and services in order to optimally support you in the implementation of your project.
dewepharma also takes on the role of authorization or registration holder for you during the procedure in the European member states.
In short, we accompany you every step of the way.
Project Start
- Portfolio analysis and development of the strategy
- Advice on differentiation from other product categories under pharmaceutical law
- Choice of authorization or registration procedure
- Establishing contact with European and national authorities
Project Implementation
Dossier Compilation
- Preparation Module 1 "Administrative Information"
- Preparation Module 2 "Assessment Reports"
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- Module 2.3 "Quality Overall Summary"
- Module 2.4 "Non-Clinical Overview"
- Module 2.5 "Clinical Overview"
- Preparation Module 3 "Quality"
- Literature research
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- Module 4 "Non-Clinic"
- Module 5 "Clinic"
- Planning and implementation of Module 1.3.4 "Readability User Test"
- Elaboration of the PIL (barrier-free) and labeling according to SPC
- Accompaniment and support during the procedure (also as a license holder)
- Processing of deficiency letters
Market Entry
- Advice on pharmaceutical advertising law
- Support in creating the print data for artwork and labeling
- Support with advertising according to the product category
- Advice and implementation of variations
- Implementation and support for renewals
- Support in the search for sales partners