Our Standard
Documentation that clears regulatory review the first time
In the indenting business, the product is only as good as the paper behind it. Every source we represent carries a complete, current regulatory documentation package — and we verify it before it ever reaches your desk.
The regulatory set
Documents behind every product we supply
The standard package your regulatory affairs and QA teams need — assembled, checked and delivered together, not drip-fed over weeks.
United States Drug Master File
Registration of the manufacturing process and controls with the USFDA — the strongest signal of a plant's documentation maturity.
Certificate of Suitability to the Monographs of the European Pharmacopoeia
EDQM certification that an API or excipient meets Ph.Eur. monograph requirements — essential for European-standard sourcing.
Active Substance Master File
The European registration dossier for active substances, held by the manufacturer and referenced by downstream users.
Certificate of Analysis
Batch-specific test results against the agreed pharmacopoeia specification, issued by the manufacturer's QC laboratory.
TSE/BSE-free declaration
Confirmation that animal-derived materials used in production are free from transmissible spongiform encephalopathies.
Safety Data Sheet (MSDS)
Handling, storage, transport and hazard information required for safe receipt and warehouse management.
WHO-GMP / EU-GMP / EXCiPACT certificate
Current Good Manufacturing Practice certification of the plant, with scope matched to the product being sourced.
Stability data & audit reports
Real-time and accelerated stability studies, plus third-party audit summaries supporting your supplier qualification.
Sourcing policy
How we qualify every source
GMP-aligned sourcing policy
No product enters our portfolio without a current GMP certificate whose scope covers the specific product, plus a documentation package we would submit ourselves. Plants with expired certificates or missing dossiers are declined — regardless of price.
Pre-qualification before presentation
We pre-qualify every plant against DGDA expectations and typical Bangladeshi customer audit standards before presenting it, so procurement and QA teams spend time only on sources that can withstand scrutiny.
Ongoing verification
Certificates are tracked for expiry, regulatory status is monitored for changes, and re-qualification is triggered by plant events — not just calendar dates.
Local regulatory support
DGDA registration & audit support
Registering a foreign source with the Directorate General of Drug Administration involves a specific document set, format and follow-up rhythm. We coordinate between your RA team, the principal and DGDA so the file moves — and we handle the principal's responses to queries in days, not months.
- Document sets formatted for DGDA submission
- Follow-up with principals on regulatory queries
- Audit visit coordination for your QA teams
- Certificate renewals & validity tracking
Our promise on paperwork
If a document exists for a product we represent, you will have a current copy in your hands within one working day of asking. If it does not exist, we will tell you that too — before you build a registration plan on it.
Quality workflow
From enquiry to batch release
-
Requirement intake
Specification, pharmacopoeia, quantity, regulatory status needed — captured in writing, confirmed with the principal.
-
Source & document screening
Plant qualification, certificate validity check, DMF/CEP/ASMF status confirmed, documentation gaps flagged before quotation.
-
Document package delivery
The complete regulatory set delivered to your RA/QA teams in the format DGDA expects — one file, everything included.
-
Sample & validation support
Samples coordinated for QC analysis and R&D trials; method queries resolved directly with the principal's technical team.
-
Batch release & after-support
COA verification per shipment, complaint coordination, and audit scheduling for as long as you buy from the source.