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 dossierCertifications & 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
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?
Do you issue a CoA for every batch?
Do you have a Drug Master File?
Are your Excipients BSE/TSE-free?
How do you verify heavy metals and lead?
Proof before promises
Give your QA team what they actually need.
Request Samples & CoA, or download the documentation index for your dossier.