Toxicology and Preclinical ServicesWith over two decades of experience in delivering comprehensive toxicology services, QPS offers high quality low cost solutions to support your IND and NDA regulatory submissions

T O X I C O L O G Y O V E R V I E W

G E N E R A L T O X I C O L O G Y

R E P R O D U C T I V E T O X I C O L O G Y

C L I N I C A L P A T H O L O G Y

G E N E T I C T O X I C O L O G Y

H I S T O P A T H O L O G Y

D M P K

B I O C O M P A T I B I L I T Y T E S T I N G

C L I N I C A L D R U G D E V E L O P M E N T

B I O A N A L Y T I C A L

P H A R M A C E U T I C A L

P R E C L I N I C A L

B I O T E C H N O L O G Y

T R A N S L A T I O N A L M E D I C I N E

G L O B A L C R O

D I S C O V E R Y

Q U A L I T Y S E R V I C E S

Introduction of QPS’ Center of Toxicology and Preclinical Services in Taiwan:

At QPS-CTPS Taiwan, our commitment is to provide our valued

customers with a fast and reliable route to clinical phase I-II

studies. We offer you a wide range of toxicity and DMPK studies

as well as other preclinical safety tests that are essential for

your preclinical drug development programs. As our valued

client, you maximally benefit from our long track record of

designing large and specialized studies.

C L I N I C A L D R U G D E V E L O P M E N T

B I O A N A L Y T I C A L

P H A R M A C E U T I C A L

P R E C L I N I C A L

B I O T E C H N O L O G Y

T R A N S L A T I O N A L M E D I C I N E

G L O B A L C R O

D I S C O V E R Y

Q U A L I T Y S E R V I C E S

Our vast experience gained from performing GLP studies and compiling

dossiers for US FDA submission for local and international

pharmaceutical and biotechnology companies within many different

disease therapies in the past decades clearly proves our ability to

effectively deliver high quality data to our customers.

Find out how to achieve your next development milestone ahead of time.

Call to schedule your tour at our toxicology and preclinical services facilities in Taipei, Taiwan.

Quality and flexibility are key factors in our work. We work closely together with you and ensure that no regulatory studies are overlooked that are required for your IND filing. As a direct result, we will design and execute the most cost effective development strategies for your drug candidates.

QPS-CTPS is an ISO/IEC 17025 certified and GLP compliant (DOH, TAF OECD), AAALAC accredited facility and is part of the Taiwanese Medical Products Agency GLP inspection program. All studies are performed in compliance with OECD GLP guidelines and complete quality assurance is performed on studies used for regulatory purposes.

The animal facility is a barrier-designed facility, which houses various species including mice, rats, hamsters, guinea pigs, rabbits and dogs. Animal care and husbandry are conducted according to AAALAC guidelines. All studies are approved by a local Animal Ethics Committee.

Chromosome Aberration Assay- In CHO cells- In human lymphocytes

Micronucleus Assays- Micronucleus assay in CHO cells- Mouse micronucleus assay

Histopathology: Tissue and Slide Preparation Tissue Image Pathology Consultation and Evaluation

US Board Certified Histopathologist

DMPK: Protein Binding Blood and Urine Sampling Plasma Concentration Dosing Formulation Analysis Distribution and Excretion

Our services include the following:

General Toxicology: Single Dose Toxicity Studies Repeated Dose Toxicity Studies- Up to 180 days in rodents and up to

9 months in non-rodents- Routes of administration: oral,

intravenous (injection and infusion), intramuscular, subcutaneous, intraperitoneal and others

- Animal species: mice, rats, guinea pigs, hamsters, rabbits and dogs

Reproductive Toxicology: Fertility Teratology- Animal species: rat and rabbit

Clinical Pathology: Urine Analyses Hermatology Serum Chemistry

Genetic Toxicology: Gene Mutation Assays- Ames Test- In Vitro mouse lymphoma assay

Biocompatibility Testing: Acute Systemic Toxicity Test Pyrogen and LAL Test- Animal species: rabbit

Intracutaneous Irritation Test Skin Sensitization Test Cytotoxicity Test In Vitro hemolysis Mutagenicity Test Implantation Test

Miscellaneous: Irritation Studies- Eye irritation test- Dermal irritation test- Animal species: rabbit

Skin Sensitization Testing- Buehler test- Maximization test- Animal species: guinea pig

General Safety Testing

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1 QPS|Taiwan

Call to arrange for a tour at QPS’ Toxicology Laboratory in Taiwan today

Time is of the essence

in drug development,

so contact a member

of the QPS Business

Development Team today

and find out what QPS

can do for you.

HQ BD Office Lily Rosa (USA)

+1 512 350 2827 info@qps.com

Company Values: Integrity - We make and keep promises and build trust through honesty, proactive communication and reliability - Quality - We bring the highest level of technical expertise and judgement to our work - Customer Focus - We tap our global resources to provide service that is fast, flexible and integrated - Commitment - We work hard to solve problems and deliver results - People - We treat people with dignity, respect and fairness, and embrace our differences - Culture - We are friendly and fun. We provide opportunities to grow, we value loyalty and teamwork, and we recognize and reward performance.