Local Bioequivalence Centre

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 Research Ward, Centre for Clinical Trial, Hospital Ampang

Address:

Clinical Research Ward (CRW),
Centre for Clinical Trial,
Level 7, Hospital Ampang,
Jalan Mewah Utara, Pandan Mewah,
68000 Ampang, Selangor.

Validity:

  1. 9 September 2014 – 9 September 2017
  2. 9 September 2017 – 8 September 2020
  3. 9 September 2020 – 8 September 2021
  4. 9 September 2021 – 8 September 2022
  5. 9 September 2022 – 8 September 2025
  6. 9 September 2025 – 8 September 2030

Contact Information:-

Telephone

+603-42896558

Fax

N/A

Email

damenthi@moh.gov.my

Contact Person

Dr. Damenthi Nair

 
Info Kinetics Sdn. Bhd.

Address:

Info Kinetics Sdn. Bhd.,
5th Floor, Gleneagles Penang,
No. 1, Jalan Pangkor,
10050 Pulau Pinang.

Validity:

  1. 30 August 2012 – 30 August 2015
  2. 14 September 2015 – 14 September 2018
  3. 14 September 2018 – 13 September 2021
  4. 14 September 2021 – 13 September 2022
  5. 14 September 2022 – 13 September 2025
  6. 14 September 2025 – 13 September 2026

Contact Information:-

Telephone

+604-228 5760

Fax

+604-228 5715

Email

tclee@info-kinetics.com

Contact Person

Dr. Lee Toong Chow

 
Questra Clinical Research Sdn. Bhd.

Address:

Questra Bio-Clinical Research Centre,
Questra Clinical Research Sdn. Bhd.,
No. 6, Jalan Desa Pauh,
Taman Desa Pauh,
13700 Permatang Pauh,
Pulau Pinang.

Validity:

  1. 30 August 2018 – 29 August 2021
  2. 30 August 2021 – 29 August 2022
  3. 30 August 2022 – 29 August 2025
  4. 30 August 2025 – 1 March 2027

Contact Information:-

Telephone

+604-390 0653, +6016-264 7056

Fax

Not applicable

Email

dayang@questra.com.my

Contact Person

Ms. Dayang Jok

 
Updated 22 October 2025
Bioxis Sdn. Bhd.

Address:

PMT 1241, Jalan Perindustrian Bukit Minyak 8,
Taman Perindustrian Bukit Minyak,
14100 Simpang Ampat,
Pulau Pinang.

Validity:

  1. 8 September 2021 – 7 September 2024
  2. 8 September 2024 – 7 September 2025
  3. 8 September 2025 - 7 September 2030

Contact Information:-

Telephone

+604-5057358

Fax

N/A

Email

bioxis2u@gmail.com
bioxis@bioxissdnbhd.com

Contact Person

Dr. Gabriel Loh Onn Kit

 
Info Kinetics Sdn. Bhd.

Address:

Info Kinetics Sdn. Bhd.,
5th Floor, Gleneagles Penang,
No. 1, Jalan Pangkor,
10050 Pulau Pinang.

Validity:

  1. 30 August 2012 – 30 August 2015
  2. 14 September 2015 – 14 September 2018
  3. 14 September 2018 – 13 September 2021
  4. 14 September 2021 – 13 September 2022
  5. 14 September 2022 – 13 September 2025
  6. 14 September 2025 – 13 September 2026

Contact Information:-

Telephone

+604-228 5760

Fax

+604-228 5715

Email

tclee@info-kinetics.com

Contact Person

Dr. Lee Toong Chow

 
Questra Clinical Research Sdn. Bhd.

Address:

Questra Bio-Clinical Research Centre,
Questra Clinical Research Sdn. Bhd.,
No. 6, Jalan Desa Pauh,
Taman Desa Pauh,
13700 Permatang Pauh,
Pulau Pinang.

Validity:

  1. 30 August 2018 – 29 August 2021
  2. 30 August 2021 – 29 August 2022
  3. 30 August 2022 – 29 August 2025
  4. 30 August 2025 – 1 March 2027

Contact Information:-

Telephone

+604-390 0653, +6016-264 7056

Fax

Not applicable

Email

dayang@questra.com.my

Contact Person

Ms. Dayang Jok

 
Updated 22 October 2025
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