Product registration and dossier support
Organised manufacturer documents and practical support for your registration files.
Registering a product means collecting a large set of documents from different sources and presenting them the way the regulator expects. Delays usually come from missing or inconsistent manufacturer files. PERAMERA helps you collect and organise the parts that depend on the ingredient and finished‑product manufacturers.
We work with your regulatory team or appointed consultant, request the documents needed for CTD‑style dossiers where available, track open requests and keep the files consistent from submission to approval and renewal.
What is included
- Checklist of manufacturer documents for your target regulator
- Collection of GMP certificates, DMF/CEP references, stability data and specifications, where available
- Document consistency checks across CoA, specifications and labels
- Support with questions from the regulator about the material
- Updates for variations and renewals
- Coordination with your regulatory consultant
Who it is for
- Regulatory affairs teams
- Brand owners registering new products
- Overseas manufacturers entering the region
- Distributors holding registrations
From request to result
Scope
Product, market and registration type.
Document plan
What is needed and who provides it.
Collection and check
Files collected, checked and organised.
Submission support
Answers to queries until approval.
Questions about product registration and dossier support
Do you submit dossiers to the regulator?
Your company or its appointed regulatory consultant submits the dossier. We collect and organise the manufacturer documents and support answers to queries.
Which markets do you support?
Egypt (EDA), Saudi Arabia (SFDA), other GCC countries and markets in Africa.
Can you help with renewals and variations?
Yes. We request updated documents from the manufacturer when certificates expire or details change.
Often combined with
Regulatory assistance
Documents organised to help you import and register products faster.
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Food supplement manufacturing and private label
From formula to finished pack: food supplements manufactured in house, under our brand or yours.
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Representation and market entry
A local partner for overseas manufacturers entering Egypt, the GCC and Africa.
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