Quality & regulatory

Paperwork your filings can stand on.

Every WLSPL batch is manufactured under WHO-GMP and ISO 9001:2015 (certified by IAF), released to five pharmacopoeias, and accompanied by the documentation your QA team needs to qualify a supplier and your RA team needs to support a filing.

Request the regulatory dossier

Certifications & standards

Certificates you can open. Audits we welcome.

WHO-GMP

Good Manufacturing Practice

ISO 9001:2015 (certified by IAF)

Quality mgmt · certified by IAF

Halal

Certified

Kosher

Certified

Verifiable certificates

Documents you can open, not just claims you can read.

A representative certificate is shown for each credential below. Batch-specific CoAs and the complete dossier are issued on request with your sample or order.

Pharmacopoeial & food standards

Every product, latest editions.

  • IP 2026 — Indian Pharmacopoeia
  • BP 2025 — British Pharmacopoeia
  • USP 47 — United States Pharmacopeia / NF
  • EP 11 — European Pharmacopoeia
  • JP 18 — Japanese Pharmacopoeia
  • FCC · Food Grade — E572 / E470a where applicable

Five-pharmacopoeia coverage on a single product means one qualified source across every market your customers export to.

The documentation package

Everything your audit needs.

  • Certificate of Analysis (CoA) — issued per batch
  • Material Safety Data Sheet (MSDS)
  • Technical Data Package (TDP) — available on request
  • Product Specification sheet
  • Statement of Origin (Vegetable/Palm), allergen/GMO/BSE-TSE-free
  • Drug Master File (DMF) — under preparation

Every claim we make is backed by a document we can place in your hands.

In-house testing & release

Verified on our own instruments, not assumed from paperwork.

Analytical lab

Assay, impurity & release testing.

Microbiology lab

Microbial limit testing.

AAS instrument

Heavy-metal & lead quantification.

Material is released only against specification — the single discipline that produces audit-ready, batch-to-batch consistency. Our vegetable/palm origin removes BSE/TSE risk at source.

FAQs

Quality & regulatory — common questions

Which certifications does Waylink hold?
WHO-GMP and ISO 9001:2015 (certified by IAF), plus Halal and Kosher certification.
Do you issue a CoA for every batch?
Yes — a batch-specific Certificate of Analysis accompanies every lot, with MSDS, TDP, specification sheet and Statements of Origin.
Do you have a Drug Master File?
A DMF is under preparation to support customer filings; TDP and specification documentation are available now.
Are your Excipients BSE/TSE-free?
Yes — stearates and Stearic Acid are 100% vegetable/palm origin, with BSE/TSE-free statements provided.
How do you verify heavy metals and lead?
In-house, on our own Atomic Absorption Spectrometer — not outsourced.

Proof before promises

Give your QA team what they actually need.

Request Samples & CoA, or download the documentation index for your dossier.