Regulatory & GMP consultancy · Malaysia +60 19-659 1775 mastura@onlinehbb.com
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Engineering, manufacturing & product companies

Manufacturers, holders and distributors

Consultancy, audit, training and registration work, listed alphabetically.

ACE Health Products Sdn Bhd Amkey Malaysia Sdn Bhd Best World Lifestyle Sdn Bhd Biofact Life Sdn Bhd BioNice Sdn Bhd DXN Pharmaceuticals Sdn Bhd Dynapharm Sdn Bhd Ecolite Bio-tech Manufacturing Sdn Bhd Farmina Bio-plus & Consultants Sdn Bhd Formapac Sdn Bhd Halagel Plant (M) Sdn Bhd Herbal Science Sdn Bhd Infinitus International (Malaysia) Sdn Bhd KCK Pharmaceuticals Sdn Bhd Matang Packaging Sdn Bhd Osmosis Nutrition Sdn Bhd Phytomedicare Sdn Bhd Ramedicare Sdn Bhd Seribu Dinar Trading Shennong Animal (M) Sdn Bhd Sunrider International (M) Sdn Bhd Sunward Pharmaceuticals Sdn Bhd Tropical Bioessence Sdn Bhd Unza Manufacturing Sdn Bhd Uraz Corporation (M) Sdn Bhd Vitarite Pharmaceuticals Sdn Bhd

Government & academic

Institutions and research facilities

Malaysia Nuclear Agency Pilot Plant, Kulliyyah of Pharmacy, International Islamic University Malaysia Pusat Pengajian Biosains & Bioteknologi, Universiti Kebangsaan Malaysia Wijaya International Medical Centre

Scope of work

What that work has covered

  • RegistrationProduct registration and updating for pharmaceuticals, supplements, traditional and veterinary products
  • NotificationCosmetic product notification and PIF compilation
  • LicensingManufacturing, import, wholesale and distribution licences; site changes; certificate amendments
  • GMP systemsDocumentation systems, Site Master File, SOPs, batch records, qualification and validation
  • AuditThird-party and in-house GMP audits with corrective action plans; vendor evaluation
  • TrainingcGMP and cleanroom aseptic technique training delivered at client sites
  • FacilityAssistance in preparation and planning design of new pharmaceutical manufacturing facilities

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