Regulatory
We provide help right across regulatory lifecycle, to ensure that dossiers are up to sratch pre-, during and post submission.
Product Registration with DCA (PBKD)
Range of services comprising of development of the dossier according to ASEAN Common Technical Dossier (ACTD) format, evaluation of the dossier and ultimately submission product registration Dossier via Quest 3+ System until attainment of product registration approval from DCA (PBKD)
• Range of Products
• Biologicals
• Vaccines
• Poison
• Non Poison
• Range of Products
• Biologicals
• Vaccines
• Poison
• Non Poison
Submission of Product Variation (Major and Minor) & Product Renewals
On behalf of the client, PQS Solution Sdn. Bhd. could assist the client is providing end to end solution in submission of application on any changes in the regulatory approvals via Quest3+ system.
Application of Manufacturing License, Import License and Wholesale License
On behalf of the client, PQS Solution Sdn. Bhd. could assist the client is providing end to end solution in submission of application for license related to Manufacturing, Importation and Wholesale of products registered with DCA/PBKD.
Application for Product Classification with NPRA
On behalf of the client, PQS Solution Sdn. Bhd. could assist the client is providing end to end solution in submission of application for product classification. This is the very first step to be carried out before a product is being registered and prior to designing of any new manufacturing plant.