01
Product Registration
Advisory, consultancy and monitoring services for product registration with the Drug Control
Authority and the national pharmaceutical regulatory agency (BPFK / NPRA, formerly NPCB),
covering the full product range: pharmaceuticals, OTC, health supplements, traditional
medicines (including homeopathy) and veterinary products.
Scope of work
- Application for digital certificate membership
- Evaluating your data and documents against the Drug Registration Guidance Document
- Assisting in compilation of the submitted documents
- Submission of required data
- Follow-up and correspondence with evaluators
Why submissions here get approved faster
Experience in manufacturing and working knowledge of local registration requirements means
data can be submitted correctly the first time. Fewer correspondence rounds during evaluation
leads to quicker approval — and materially less of your time spent on it.
02
Cosmetic Product Notification & PIF Compilation
Since 1 January 2008, all cosmetic products must be notified with the national pharmaceutical
regulatory agency by the company or person responsible for placing the product on the market.
It is an offence to manufacture or import a cosmetic product without prior notification.
HBB assists in obtaining your product notification within a short period and at a competitive
fee.
Scope of work
- Evaluating your product formula against the Guidelines for Control of Cosmetic Products in Malaysia
- Assisting in preparation of related documents for notification
- Notification submission and follow-up
What is a PIF, and why it matters
A Product Information File is the set of technical, certificate, safety and other product data
required under the ASEAN Cosmetic Directive, and it must be readily accessible for inspection
by the cosmetic regulatory authority. The company or person placing the product on the market is
responsible for producing the PIF when requested.
Interpreting the technical terms and data required by the guideline is not straightforward. HBB
compiles, evaluates and arranges the data so that it can be retrieved whenever it's needed —
rather than reassembled from scratch during an inspection.
03
Licence Applications
Premises for importers, manufacturers and wholesalers must be licensed. HBB handles the
application work for the licences and approvals this industry requires:
- Manufacturing licence application & renewals
- Distribution licence application
- Import / wholesale licence
- Product Certificate of Free Sale
- Application for change of manufacturing site
- Amendment of product registration certificates
- Advertisement approval from the Medicine Advertisement Board (KKLIU number)
04
Regulatory Affairs & Other Related Work
Regulation-related work beyond filing, carried out as standalone engagements or on retainer:
- Review of product formula — herbal and cosmetic
- Review of product formula for health supplements
- Product classification
- Evaluation of a product label, outer box and/or leaflet
- Evaluation of premises for GSP / import licence application
- Application or renewal of smartcard
05
GMP & GDP Consultation for Manufacturing Plants
The Authority's role is to ensure the safety, quality and efficacy of pharmaceuticals, health,
traditional, veterinary and personal care products marketed in Malaysia. To achieve that,
premises for importers, manufacturers and wholesalers must be licensed.
With experience in manufacturing plants and product registration, HBB helps you maintain GMP
compliance — providing technical input into CAPA and acting as visiting consultant on a retainer
basis. Through periodic visits, your system is reviewed and corrective actions are proposed for
identified GMP weaknesses, rather than waiting for an inspection to surface them.
Delivery models
- Retainer / visiting consultant — periodic site visits on an agreed schedule
- CAPA and deviation support — technical input into root cause and corrective actions
- Pre-inspection readiness — targeted support ahead of a regulatory inspection
06
GMP Trainings
GMP is the most effective tool for assuring safe, quality and efficacious production of
pharmaceutical products — including pharmaceuticals, health, traditional, cosmetic and
veterinary. Regulatory guidelines for manufacturing state clearly that regular, continuous
training must be provided to personnel so they understand GMP principles in their daily work.
Most training providers cater to senior key personnel and management. To fill that gap, HBB
offers 8 standard GMP training modules aimed at supporting key personnel —
junior executives, supervisors, line leaders and operators — so the message carries through to
the people doing the work.
The 8 standard modules
- M1 — Basic GMP
- M2 — Basic Documentation
- M3 — Basic Hygiene
- M4 — Control & Handling of Materials
- M5 — Packaging Process
- M6 — IPQC & Area Clearance
- M7 — Internal Audit
- M8 — Good Distribution Practice (covering Good Storage Practice)
All training is arranged as in-house training, so more personnel benefit from the same session.
For subjects outside these modules, programmes can be tailored to suit your needs.
See training detail & how sessions run
07
GMP / Quality Audit & Vendor Evaluation
Self-inspection should be conducted to monitor compliance with GMP principles, at intervals
following a pre-arranged programme. With years of manufacturing-plant and consultation
experience, HBB delivers a thorough in-house GMP audit and proposes corrective action plans.
What you receive
- A structured audit against applicable GMP requirements
- A written report of the defects and weaknesses found
- Proposed corrective action plans to rectify them
Vendor evaluation
Vendor evaluation is a basic element of achieving quality products — quality begins at the level
of materials supplied by your chosen vendors. Evaluating their level of quality understanding
gives you assurance that the materials supplied are consistently to the standards set.
08
Basic GMP Documentation
A good documentation system is an essential part of a quality assurance programme. Clear,
legible documentation prevents errors arising from spoken communication and allows traceability
of batch history.
HBB provides consultation for the development of a basic GMP documentation system for
manufacturing operations, in compliance with current operational needs and GMP.
Documents we help prepare
- Site Master File (SMF)
- GMP document control system
- Job descriptions
- General SOPs for production operation, QA activities, maintenance, store and others
- Batch Manufacturing Master Records
- Monitoring records — in-process quality control, environmental records and similar
- Documentation for qualification & validation
- Contract agreements between manufacturer and contract giver, or with contract laboratories, from a GMP perspective
Where your needs fall outside these, the work is tailored to suit your requirements.
09
Other Services / Technical Sourcing
Through associates in adjacent specialisations, HBB can connect you to services outside its own
scope. If you are looking for any of the following, get in touch:
- Contract manufacturers
- Contract laboratory services
- Laboratory equipment suppliers
- Laboratory utensil suppliers
- Uniform suppliers
- Equipment calibration services