Regulatory & GMP consultancy · Malaysia +60 19-659 1775 mastura@onlinehbb.com
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Tell us what you're trying to get approved.

The most useful first message contains three things: what the product is, which market you're placing it in, and where you're stuck — formula stage, ready to submit, already submitted with queries, or preparing for an inspection. From that, you'll get a straight answer about which service applies and what it involves.

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Before you write

Answers to the questions we're asked most

How long does product registration take?

It depends on the product category and how complete the dossier is at submission. The single biggest variable you control is whether the data is compiled against the current guidance document — that is what determines how many correspondence rounds you go through, and correspondence rounds are what stretch timelines.

Do I need a PIF if I only sell cosmetics locally?

Notification is a legal requirement before a cosmetic product is manufactured or imported. The Product Information File is separate: it must be compiled and made readily accessible for inspection on request. Being unable to produce it when asked is the risk — not having notification alone is not enough.

Can you work with a very small company?

Yes — that is a deliberate part of what HBB does. The consultancy was set up to serve small and medium Malaysian manufacturers, holders, distributors and wholesalers at rates these businesses can carry, without lowering the regulatory standard.

Do you train staff who aren't managers?

That is precisely who the eight standard modules are for: junior executives, supervisors, line leaders and operators. Most providers train management only, which is why the gap exists.

We already have a QMS. Why would we need a GMP audit?

Self-inspection is itself a GMP requirement, to be carried out at intervals according to a pre-arranged programme. An independent audit finds the weaknesses an internal review tends to overlook, and produces a written report with proposed corrective action plans you can work through.