Regulatory assistance
Documents organised to help you import and register products faster.
Regulators and customs authorities expect a complete, consistent document set. Missing a single certificate can hold a shipment at the port or delay a registration by months. PERAMERA organises the documents that come with every material so your regulatory and import teams have what they need from the first quote.
Every lot ships with a Certificate of Analysis. We provide the MSDS and technical files, and we request manufacturer documents such as GMP certificates, DMF or CEP references, stability data and statements on TSE/BSE, residual solvents or allergens where the manufacturer makes them available.
What is included
- Certificate of Analysis (CoA) with every lot
- Material Safety Data Sheet (MSDS/SDS)
- Technical data sheets and specifications
- Manufacturer GMP certificates, where available
- DMF or CEP references and open parts, where available
- Statements on TSE/BSE, residual solvents, allergens and origin on request
- Certificates of origin and shipping documents for customs
Who it is for
- Regulatory affairs teams
- Import and supply‑chain teams
- Quality assurance departments
- Distributors registering products
From request to result
Tell us the destination
Country, regulator and whether the material is for import, registration or both.
We list the documents
A checklist of what the manufacturer can provide for that product.
Documents collected
We collect, check and organise the files for you.
Ready for your submission
Your team receives a complete set before or with the shipment.
Questions about regulatory assistance
Do you provide a CoA with every shipment?
Yes. Every lot ships with its own Certificate of Analysis.
Can you provide a DMF or CEP?
We request DMF or CEP references and supporting documents from the manufacturer. Availability depends on the product and manufacturer, and we tell you before you order.
Which regulators do your documents support?
Our customers use them with the Egyptian Drug Authority (EDA), the Saudi Food and Drug Authority (SFDA), other GCC health authorities and national regulators in Africa.
Often combined with
Product registration and dossier support
Organised manufacturer documents and practical support for your registration files.
Learn more →
Quality testing and supplier qualification
Extra confidence in every lot: independent testing, supplier documents and audit support.
Learn more →
Logistics handling
Competitive freight rates, faster delivery and order fulfilment you do not need to chase.
Learn more →