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9 March, 2023

Mean Kinetic Temperature – MKT

1. Introduction Mean Kinetic Temperature (MKT) is used in the pharmaceutical industry to evaluate the effect fluctuating temperatures have over time on the efficacy and safety […]
2 March, 2023

Comparing Attributes of the ASEAN Medical Device Directive and EU 2017/745 Regulation (Session 1)

When medical device manufacturers consider placing devices on the market, they face the challenge of understanding the regulatory environment in different jurisdictions and the regulatory requirements […]
27 February, 2023

Scientific Conference: “Quality Management By Cloud Computing: Comprehensive Solution Through MasterControl Application.”

Today, Friday, February 24, 2023, the seminar program “Quality management by cloud computing: Comprehensive solution through Master Control application took place with the participation of more […]
5 January, 2023

Transfer Of Analytical Methods Between Two Units And Laboratories

At present, technology transfer in general, and transfer analytical method, in particular, is a problems of great concern for factories or laboratories. The transfer of analytical […]
30 December, 2022

Orphan Drug Designation

An orphan drug designation is a status delivered by FDA (US) or EMA (Europe) for pharmaceutical drug that has been developed specifically to treat an ultra-rare […]
14 December, 2022

Pharmaceutical Quality System (PQS)

Overview Patient safety is the primary objective of the Pharmaceutical Quality System (PQS), Manufacturing Authorization holder is required to manufacture safe and effective medicinal products in […]

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2 March, 2023

Comparing Attributes of the ASEAN Medical Device Directive and EU 2017/745 Regulation (Session 1)

When medical device manufacturers consider placing devices on the market, they face the challenge of understanding the regulatory environment in different jurisdictions and the regulatory requirements […]
27 February, 2023

Scientific Conference: “Quality Management By Cloud Computing: Comprehensive Solution Through MasterControl Application.”

Today, Friday, February 24, 2023, the seminar program “Quality management by cloud computing: Comprehensive solution through Master Control application took place with the participation of more […]
5 January, 2023

Transfer Of Analytical Methods Between Two Units And Laboratories

At present, technology transfer in general, and transfer analytical method, in particular, is a problems of great concern for factories or laboratories. The transfer of analytical […]
30 December, 2022

Orphan Drug Designation

An orphan drug designation is a status delivered by FDA (US) or EMA (Europe) for pharmaceutical drug that has been developed specifically to treat an ultra-rare […]
14 December, 2022

Pharmaceutical Quality System (PQS)

Overview Patient safety is the primary objective of the Pharmaceutical Quality System (PQS), Manufacturing Authorization holder is required to manufacture safe and effective medicinal products in […]
24 November, 2022

Workshop On “Exchange Of Experience In Upgrading The Quality System Of A Pharmaceutical Production Facility To EU – GMP Standards” By OrioledHub And Equilab

On the morning of November 24, the Workshop on “Exchange of experience in upgrading the quality system of a pharmaceutical production facility to EU – GMP […]
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