Dossier compilation
Authoring and assembly of Modules 1–5 in CTD, eCTD or ACTD format, including Quality Overall Summary, expert reports and country-specific Module 1 requirements.
Regulatory affairs
From dossier to marketing authorization. We take the APIs and finished dosage forms we source — or the ones you already have — through registration, inspection and lifecycle maintenance in your target markets.
ProductsAPI · FDF · Excipients
FormatsCTD · eCTD · ACTD
ModalitiesGenerics · Biosimilars
ScopePre-submission to post-approval
Sourcing and registration, handled by one team
A supply agreement is only valuable once the product is approved. Our regulatory team works alongside our sourcing and CDMO partners, so the quality documents, GMP evidence and stability data you need for submission are planned from the first purchase order — not requested after the fact.
Whether you are bringing an API into a new market, filing a generic FDF, or navigating a biosimilar pathway, we prepare the dossier, manage the authority correspondence and keep the authorization current after approval.
What we cover
Engage us for a single module or for the whole registration programme.
Product registration
Submission and follow-up of marketing authorization applications for FDFs, including authority queries, deficiency letters, sample and reference-standard logistics, and approval tracking.
API regulatory support
DMF and ASMF preparation (open and restricted parts), CEP applications and revisions, and supplier regulatory audits so the API behind your product is ready to be referenced.
GMP & site compliance
Manufacturing-site registration, GMP certificate submissions, inspection readiness and CAPA follow-up for the API and FDF sites behind each application.
Lifecycle management
Variations, renewals, site and supplier changes, labelling updates and post-approval commitments, scheduled so no authorization lapses.
Strategy & dossier gap analysis
Pathway selection, pre-submission assessment and due-diligence review of existing dossiers — so you know what is missing before the authority tells you.
Four stages, one accountable contact
Assess
We map the target markets, confirm the pathway and list every document, study and certificate the submission will need.
Prepare
We collect data from manufacturers and partners, author the modules and close gaps before anything is filed.
Submit
We file with the authority, manage queries and deficiency letters, and keep you updated at every milestone.
Maintain
After approval we own the variation and renewal calendar so the authorization stays valid as the product evolves.
Where we file
We prepare and submit applications in the markets where Hanpars supplies product, and support partner filings elsewhere through our regulatory network.
- Iran (IFDA)
- Türkiye (TİTCK)
- GCC and wider MENA
- CIS markets
- CEP / ASMF via EDQM
Common questions
Do you only register products that Hanpars supplies?
No. Regulatory affairs is offered as a standalone service. Many clients bring their own API or FDF and use us for the dossier and the submission only.
Can you work from an existing CTD dossier?
Yes. We start with a gap analysis against the target authority's requirements, then adapt Module 1 and any country-specific sections rather than rebuilding what already works.
How long does a registration take?
It depends on the authority, the product class and how complete the source data is. After the assessment stage we give you a dated plan with the authority's published review timelines and our preparation time.
Do you handle biosimilars?
Yes. Our team has direct experience with biosimilar and biotech-derived product submissions, including comparability packages and technology-transfer documentation.
Tell us the product and the market
We will come back with the pathway, the document list and an indicative timeline — before any commitment.
Telephone+98 21 8885 6347 · office hours 09:00–17:00, Tehran
OfficeHaniya Parsan Darou, 3rd floor, No. 326, Zafar Street, Africa Boulevard, Tehran 1968734974, Iran
Emailcontact@hanpars.com