BE Test

Local Bioequivalence Centre Foreign Bioequivalence Centre BE Centres/Sites which certificate has expired Guidelines Application Forms

Local Bioequivalence (BE) Studies Centres

As of 1 January 2020, NPRA had revised the way the clinical and bioanalytical facilities under the NPRA BE Centre Compliance Programme. Clinical and bioanalytical facilities are listed separately and may collaborate freely with any other listed facilities. Collaborating facilities must ensure that different phases (clinical & bioanalytical) of the BE study are conducted within the listing period.

Failure to do so may result in the BE study report to be rejected during product registration submission.

Clinical Facilities

The following clinical facilities are updated as of 15 September 2021.

Borneo Kinetics Sdn. Bhd.

Address	:	Borneo Kinetics Sdn. Bhd., CRC Research Ward, Level 6, Ward Block, Sarawak Heart Centre (Pusat Jantung Sarawak), 94300 Kota Samarahan, Sarawak.
Contact Information:-
Telephone	:	+6082 668 111
Fax	:	+6082 668 025
Email	:	wntiong.bksb@gmail.com borneokinetics@gmail.com
Contact Person	:	Tiong Wen Ni
Status:-
Validity	:	I. 18 September 2013 - 18 September 2016 II. 18 September 2016 - 17 September 2019 III. 18 September 2019 - 17 September 2022

Clinical Research Ward, Clinical Trial Unit, Clinical Research Centre

Info Kinetics Sdn Bhd.

Clinical Research Centre Hospital Seberang Jaya

Clinical Research Centre Perak (CRC Perak)

Questra Clinical Research Sdn. Bhd.

Bioanalytical Facilities

The following bioanalytical facilities are updated as of 15 September 2021.

Info Kinetics Sdn Bhd.

Address	:	Info Kinetics Sdn Bhd., 5th Floor, Gleneagles Penang No. 1, Jalan Pangkor, 10050 Pulau Pinang
Contact Information:-
Telephone	:	+604-228 5760
Fax	:	+604-228 5715
Email	:	tclee@info-kinetics.com
Contact Person	:	Dr. Lee Toong Chow
Status:-
Validity	:	I. 30 August 2012 – 30 August 2015 II. 14 September 2015 – 14 September 2018 III. 14 September 2018 – 13 September 2021 IV. 14 September 2021 - 13 September 2022

Pusat Kajian Bioekuivalens (BE), Pharmacy-Attest Research Sdn Bhd (ARSB) BA/BE Centre, Pusat Pengajian Sains Farmasi, Universiti Sains Malaysia (USM)

Questra Clinical Research Sdn. Bhd.

Bioxis Sdn. Bhd.

Local Bioequivalence (BE) Studies Centres

Clinical Facilities

Bioanalytical Facilities

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Address	:	Attest Research Sdn. Bhd. Lot 16030, Plot 88G, Lintang Bayan Lepas 10, Kawasan Perindustrian Bayan Lepas, 11900 Bayan Lepas, Pulau Pinang
Contact Information:-
Telephone	:	+604-656 9040
Fax	:	+604-659 6517
Email	:	khyuen@usm.my
Contact Person	:	Prof. Yuen Kah Hay
Status:-
Validity	:	23 October 2018 – 22 October 2021 23 October 2021 - 22 October 2022