Contents

Business Areas

The best partner for precision medicine

CRO

The New Drug Development Business Unit (BU) has partnerships
with various domestic and international pharmaceutical companies
and medical institutions and provides clinical and analytical services
throughout the entire new drug development process.

It is the first company in Korea to specialize in vivarium research, and received GLP certification
in the area of non-clinical trial toxicity testing and analysis in 2005.

Analysis Service

A specialized institution for analyzing biological specimens at a global level

Invites BioCore's analysis services obtained GLP certification in the field of analytical testing for non-clinical toxicology studies during
the 2005, following their start of clinical trial specimen analysis in 2001, making us the first company in Korea to do so. We have
accumulated unique analytical technology and know-how for over 20 years, and have also introduced state-of-the-art analysis
equipment and established a robust system.
We also provide accurate and reliable results based on standard operating procedures that comply with ICH, GCP,
and domestic and international regulations and standards.

Analysis service item
  • Method establishment and development
  • Clinical trial sample analysis: BA, BE, DDI, FE Study
  • Non-clinical test sample analysis: TK Study
  • Ligand Binding Assay
Analyses List Download
  • Analytical test during toxicokinetic study
  • Analytical test during non-clinical study
  • In vivo dynamics analysis of drugs
  • Development of drug analysis methods in biological samples and analysis method verification tests
  • Comparative dissolution tests
  • Biomarker analysis services
Analysis equipment introduction

SCIEX

  • SCIEX TQ 7500

  • SCIEX TQ 6500+

  • SCIEX Qtrap 6500

  • SCIEX TQ 5500+

  • SCIEX Qtrap 5500

  • SCIEX TQ 5500

  • SCIEX API 5000

  • SCIEX Qtrap 4000

  • SCIEX API 4000

WATERS

  • Xevo TQ-S

  • Xevo TQ-XS

Mass spectrometer(LC-MS / MS)
Equipment name Manufacturer Model name Quantity possessed
Mass spectrometer
(LC-MS / MS)		 SCIEX TQ 7500 1
TQ 6500+ 1
Qtrap 6500 1
TQ 5500+ 2
Qtrap 5500 1
TQ 5500 3
API 5000 3
Qtrap 4000 1
API 4000 3
WATERS Xevo TQ-S 1
Xevo TQ-XS 4
Clinical Services

A leader in early clinical trials,
the best partner for pharmaceutical companies

Invites BioCore’s clinical services have focused on early-stage clinical trials as a specialized research institution
for in vivo testing, making them the first of their kind in Korea to conduct clinical trials
with particular emphasis on this area.

Clinical Service Items
  • PROJECT STRATEGIC
    PLANNING SERVICES
  • MEDICAL TRANSLATION
    SERVICES
  • CLINICAL RESEARCH
    SERVICES
  • QUALITY ASSURANCE
    SERVICES
  • MONITORING
    SERVICES
  • DATA MANAGEMENT
    SERVICES
Test Procedure
01. Trial preparation
  • Preliminary investigation
  • Clinical trial design
  • Site selection & Investor selection
  • Draft submission and approval (IRB,MFDS)
02. Trial conduct
  • Pre-meeting
  • Receipt of subject consent & patient testing
  • Subject registration
  • Randomization
  • Conducting subject testing
  • AE/SAE reporting
  • Inspection by clinical trial client
  • Monitoring
  • CRF&SOURCE Document Classification
  • Entering and verifying data
03. Trial completion
  • Document organization and analysis
  • Report writing
  • Submission to IRB and MFDS
Our Partners
Pharmaceutical
Quality Control

One Stop - from development to quality control after shipment

Invites BioCore's Pharmaceutical Quality Control Testing Laboratory was established through the acquisition
and merger of C&C Labs Co., Ltd., designated as No. 35 by the Ministry of Food and Drug Safety, based on accumulated pharmaceutical research
and development experience gained through various product analysis experiences.
Our laboratory complies with the relevant regulations of the Ministry of Food and Drug Safety, and provides services that fully meet
all the needs of our clients throughout the entire process from development to post-market quality control.

Service Item
  • Pharmaceutical quality control testing, analysis testing
  • Emergency testing for Ministry of Food and Drug Safety inspection order
  • Impurity testing
    (NDMA, metal impurities, etc.)
  • Testing for licensed pharmaceutical products
    (batch release, equivalence testing, etc.)
  • Pharmaceutical stability testing
Test Items
NO. Testing items
1 Appearance
2 pH
3 Confirmatory test(TLC)
4 Confirmatory test(HPLC)
5 Preservative confirmation test
6 Mass and volume test
7 Pressure testing
8 Uniformity of dosage unit testing (mass variation testing)
9 Dissolution testing(UV-Vis)
10 High-Performance Liquid Chromatography (HPLC)
11 Content testing(HPLC)
12 Content testing(GC)
13 Content testing(UV-Vis)
14 Content testing(Appropriate)
15 Preservative testing(HPLC)
16 Metal impurity analysis (7 types, 17 types, 24 types)
17 Nitrosamine analysis test (LC-MS/MS, GC-MS/MS)
18 Pharmaceutical validation
Test Procedure
01. Test Request
  • Estimation Consultation
  • Contracting
  • Preliminary Inspection
02. Test Execution
  • Validation
  • Analytical Testing
  • Instrumental Analysis Testing
03. Test Completion
  • Test Result Confirmation
  • Issuance of Test Report
About the Testing Equipment

  • HPLC

  • GC-FID, Head space

  • GC-MS/MS

  • ICP-MS

  • 용출기

  • 안정성챔버

equipment name manufacturer system and model name quantity possessed
High-performance liquid chromatography
(HLPC-VWD)		 Waters Alliance HPLC system 1
High-performance liquid chromatography
(HPLC-VWD,PDA)		 Waters Alliance HPLC system 1
High-performance liquid chromatography
(HPLC-VWD)		 Agilent Technologies 1260 Infinity Ⅱ LC system 1
Gas chromatography
(GC-FID, Head space)		 Agilent Technologies 8890 GC system 1
Ultraviolet-visible spectrophotometer
(UV-VIS Spectrophotometer)		 KLAB OPTIZEN™ Alpha 1
Equipment for dissolution testing
(Dissolution Tester)		 ERWEKA DT 1610 Series 1
Equipment for dissolution testing
(Dissolution Tester)		 Agilent Technologies 708-DS 1
Conductivity Meter Thermo Scientific ORION STAR A212 1
Osmometer GONOTEC OSTOMAT 3000-D 1
pH Meter OHAUS ST3100 1
Micro Balance METTER TOLEDO MX5 1
Semi-Micro Balance OHAUS EX125 1
Balance OHAUS PX2202KR 1
Mass analyzer
(LC-MS/MS)		 SCIEX TQ 6500+,
TQ 5500 		1
Our inventory includes more than 70 types of equipment, in addition to the main equipment.
Go to top