Established 2011 · Malaysia
Get your health product approved in Malaysia — without the back-and-forth.
From regulatory requirements to GMP compliance, we help turn complex requirements into practical solutions.
Why submissions get delayed
Most rejections and delays come from documents compiled against the wrong guidance.
Registration, notification and licensing in Malaysia each run on a specific guidance document. When a dossier is assembled without checking it against that document first, the result is a string of queries from the evaluator — and months lost. HBB's approach is to front-load that check, so the data submitted is right the first time.
You're a manufacturer
You need licensing, a GMP system that stands up to inspection, and staff who know the rules.
You're a product holder or brand
You have a product ready for market and need it registered, notified or classified.
You're importing or distributing
You need the right licence, a compliant store, and vendors you can vouch for.
Services
Nine services, grouped by what stage you're at.
Pick the bucket that matches where you are. Each links to the full scope of work.
Product approval & licensing
For companies with a product ready to be registered, notified or licensed in Malaysia.
- Product registrationHealth supplements and traditional products (including homeopathy) — advisory, dossier compilation, submission and follow-up with the Drug Control Authority / BPFK.
- Cosmetic product notification & PIF compilationNotification filing plus Product Information File compiled to ASEAN Cosmetic Directive requirements.
- Licence applicationsManufacturing, distribution, import and wholesale licences; change of site; certificate amendments; Certificate of Free Sales; KKLIU advertisement approvals.
GMP & quality systems
For plants that need to pass an inspection, or hold a certification they already have.
- GMP / GDP consultationRetainer or visiting-consultant support for manufacturing plants — technical input into CAPA and corrective actions on identified GMP weaknesses.
- GMP / quality audit & vendor evaluationIn-house GMP audit with a written report of defects and weaknesses, plus proposed corrective action plans; supplier and vendor quality assessment.
- Basic GMP documentationSite Master File, document control system, job descriptions, SOPs, Batch Manufacturing Master Records, qualification & validation documentation.
- Regulatory affairs & related workFormula review, product classification, label and leaflet evaluation, GSP/import store evaluation, smartcard applications and renewals.
Training & technical sourcing
For teams who need the knowledge in-house, not only outsourced.
- GMP training — 8 standard modulesIn-house programmes aimed at junior executives, supervisors, line leaders and operators, not only management. Cleanroom aseptic technique training available.
- Technical sourcingContract manufacturers, contract laboratories, lab equipment and utensil suppliers, uniform suppliers and equipment calibration services.
How we work
You always know which step you're on.
Applicable to registration, notification and licensing work alike.
Gap check
Your product data and documents are reviewed against the current guidance document. You're told what's missing before anything is submitted.
Compile & submit
Dossier assembled and submitted, including digital certificate membership where required. You receive a copy of exactly what went in.
Follow up
Correspondence and queries from BPFK evaluators are handled directly, so you're not decoding them alone.
Approval & after
Approval handed over with the maintenance requirements — variations, renewals, smartcard and inspection cycle.
Our experience
Regulatory and GMP expertise across Malaysia.
15+ years — HBB Services Solution has provided consultancy, audit, training and product registration support to more than 50 companies across the pharmaceutical, supplement, traditional medicine and cosmetic industries.
The consultant
Mastura Nordin
B.Biomed.Sc. (Hons), Universiti Kebangsaan Malaysia. Mastura began her career in sterile pharmaceutical manufacturing, progressing from Production Executive to Operations Manager before founding HBB Services Solution in 2011. She has extensive experience in cGMP, qualification and validation, with hands-on experience across pharmaceutical manufacturing facilities in Malaysia.
Tell us what you're trying to get approved.
Send the product type and where you're stuck. You'll get a straight answer on whether it's a registration, a notification, a licensing or a compliance matter — and what it involves.
Start an enquiry WhatsApp +60 19-659 1775