About BIO-INNOVA

An OverviewBIO-INNOVA Co., Ltd. Clinical Research Organization (CRO), was established in Bangkok - 8th March 2006

BIO-INNOVA offers professional services in the areas of clinical research, pharmacokinetics, bioavailability, bioequivalence, statistics and data management.

Our commitment is to best serve our clients to achieve their needs and exceed their expectation with a vast scientific experrtise and quality team for pharmaceutical, biotechnology and medical device industries. We do value our close collaborative partnerships and will assist our clients to control study cost, accelerate introduction of products to the market, minimize risks and minimize return on investment.

Our ResourcesWe serve our clients with state-of-the-art clinical research facilities with appropriate recreation, dining and entertaining functions for volunteers,

Our modern in-house 60 beds (more than 4,000 volunteers database, 5 principal/clinical investigators) are available for early clinical trials, bioavailability and bioequivalence studies with special care and treatment from our well-trained medical professionals. All clinical studies are conducted strictly in compliance with ICH+GCP requirements.

Our modern bio-analytical facilities, operated by expert scientists, is complied with the Good Laboratory Practice (GLP) and ISO/IEC 17025 requirements. 6 UPCL-MS/MS, more than 100 validated methods, 6 deep freezers)

2006

MARCH 2006

First Private CRO in Thailand

Settle by Dr. Saitorn

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2007

FEBRUARY 2007

Thai FDA visit

AUGUST 2007

ICH-GCP compliance

DECEMBER 2007

CPhi, Milan

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2008

DECEMBER 2008

ISO/IEC 17025 the 1st accreditation 24 Dec’08

DECEMBER 2008

CPhi, Frankfurt

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2009

JANUARY 2009

OECD-GLP compliance

MARCH 2009

Co-speaker with Thai FDA on GCP Training for Local CRO & Thai Pharmaceutical companies

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2010

JULY 2010

CPhi, Paris

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2011

JUNE 2011

ISO/IEC 17025 the 2nd renewal accreditation 29 Jun’11

SEPTEMBER 2009

GLP the 1st accreditation 07 Sep’11

JUNE 2011

DIA, Chicago Jun’11

OCTOBER 2011

CPHI, Frankfurt Oct’11

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2012-2014

OCTOBER 2012

CPHI, Madrid Oct’12

MARCH 2013

ISO/IEC 17025 the 3rd renewal accreditation 04 Mar’13

JULY 2013

Mock Inspection-Thai FDA 17-18 Jul’13

JANUARY 2014

Malaysian FDA certificate 28 Jan’14

MAY 2014

GLP the 2nd renewal accreditation 12 May’14

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2015-2017

NOVEMBER 2015

ISO/IEC 17025 the 4th renewal accreditation 11 Nov’15

NOVEMBER 2016

Thai FDA Mock Inspection 17 Nov’16

JANUARY 2017

GLP the 3rd renewal accreditation 13 Jan’17

FEBRUARY 2017

Malaysian FDA 2nd Accreditation 08 Feb’17

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2018-2020

JUNE 2018

ISO/IEC 17025 the 5th renewal accreditation 07 Jun’18

AUGUST 2018

Received Quality Award from DMSc 03 Aug’18

APRIL 2019

Thai FDA-MY FDA Mock Inspection 23-26 Apr’19

JANUARY 2020

Malaysian FDA 3rd Accreditation 28 Jan’20

DECEMBER 2020

ISO/IEC 17025 6th accreditation 08 Dec’20

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2021-2022

JUNE-JULY 2022

Company Name Change TFDA & ASEAN accepted us to be 1 of BE center for ASEAN mock inspection during 27 Jun’22-01 Jul’22 or 04-08 Aug’22. We will be recognized among ASEAN

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