Pre-Clinical Unit

Discovery to Development - An Absolute Strategy-Driven Process

Our Pre-Clinical unit is an OECD GLP-certified, CPCSEA-registered, and FDCA-approved laboratory, which operates as Contract Research Organization (CRO) and Public Testing Laboratory.

Toxicology, mutagenicity, analytical, batch release tests, and other non-clinical studies are just a few of the non-clinical studies for which we provide complete solutions for integrated drug development via PoC / efficacy.

Our CRO also offers an end-to-end solution for drug development programs i.e., from NCE synthesis to clinical trials. Additionally, our CRO provides a full range of services for drug development projects, including NCE synthesis to clinical trials.

We offer regulatory solutions related to non-clinical testing of pharmaceutical/biotechnology products, vaccines, cosmetic products, veterinary drugs as well as food additives, feed additives, industrial chemicals and medical devices.

Our CRO also offers an end-to-end solution for drug development programs i.e., from NCE synthesis to clinical trials. Additionally, our CRO provides a full range of services for drug development projects, including NCE synthesis to clinical trials.

We offer expertise in a variety of areas, including APIs and formulations, recombinant and gene therapy products and vaccines, herbal remedies, nutraceuticals, medical devices, and the chemical and agrochemical industries. We have conducted various collaborative IND filing projects for Cadila
Pharmaceuticals Ltd and its biotechnology division. Additionally, we have conducted research with leading institutions, mainly in the United States and Europe.

Key Highlights:

  • Widespread research partners across the globe
  • >5 IND submissions
  • Successful dossier submission by the sponsor in USFDA for first in world vaccin
  • Audited by various regulatory/competent authorities:
    • NGCMA, Govt. of India for compliance of OECD Principles of GLP
    • CPCSEA inspectors
    • State FDA
    • ISO
    • Sponsor / professional auditors
  • The Public Testing Laboratory (PTL) of the CRO is approved (licensed) by Food & Drug
    Control Administration (FDCA), Gujarat for carrying out biological Pharmacopoeia
    test/batch release tests on various products.

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Accreditations

We have received various accreditations from well-renowned organizations. These are a testament to our commitment of providing quality products and a strive for excellence in everything we do.

Areas Of Expertise

We are the one-stop solution for all your basic and regulatory research needs including drug development programs from NCE synthesis to clinical trials.

Our basic research / discovery activities support the clients in fast-track screening of molecules, efficacy studies using animal models for lead compound & ADME ((PK & other studies).

Our GMP GLP-certified laboratory offers regulatory research in toxicology, mutagenicity and supporting analytical studies following national/international test guidelines i.e., OECD, WHO, ICH, D & C act & rule, etc.

Our Public testing laboratory offers testing of drugs specified in schedule C & C(1) – parenteral preparation for Pyrogen & Toxicity Testing.

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Cro Portfolio

Our CRO portfolio includes Animal supply (breeding and trading of animas for experiments), Discovery (Pharmacology & Microbiology Efficacy) and Regulatory research (Toxicology, Mutagenicity & Analytical Chemistry). The facility is registered with CPCSEA for the breeding and supply of animals for in-house experiments and trading.

Breeding & trading of animals: Below mentioned animal colonies are maintained by in-breeding, out-breeding, or random breeding systems as per the species characteristics.

  • Wistar rats
  • New Zealand White rabbits
  • Dunkin Hartley Guinea pigs
  • Mice
    • Swiss albino mice
    • Balb/c mice
    • C57BL/6J mice
    • DBA/2J mice

Discovery & regulatory research: we offer a wide range of non-clinical in vivio, in vitro & analytical studies.

Basic research (Discovery) – Model Development & efficacy

  • Anti-diabetic
  • Anti-Inflammatory
  • Anti-Infective
  • Sepsis management
  • Sleep & Stress management
  • GIT motility
  • Intra Ocular Pressure (IOP)
  • COPD management
  • Neutropenia management
  • Hepatoprotection against Liver injury
  • Anti-atherosclerotic activity
  • Solid tumor management
  • Anticoagulant & anti-platelet activity
  • Heparin activity
  • Immunogenicity
  • Gene therapy candidate
  • Antibody generation
  • ADME (PK & Tissue distribution)
  • Maximum tolerated dose (MTD) evaluation
  • Pharmacopoeia release test (IP, BP, EP, USP)
  • And many more

Regulatory research:

  • Toxicology
    • Acute toxicity
    • Sub-acute toxicity studies
    • Sub-chronic toxicity studies
    • Chronic toxicity studies
    • Male fertility
    • Skin sensitization testing
  • Mutagenicity
    • AMES test (bacterial reverse mutation test)
    • Chromosomal aberration test (in vivo)
    • Micronucleus test (in vivo)
  • Analytical
    • Analytical Chemistry
    • Method Validation & Formulation analysis

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Facilities

The state-of-the-art facility is spread over more than 11500 square feet which include animal breeding, experimentation rooms and support laboratories.

Brisket ball tip cow sirloin. Chuck porchetta kielbasa pork chop doner sirloin, bacon beef brisket ball tip short ribs.

Vivarium

  • The vivarium has separate areas/rooms for breeding/efficacy and GLP experiments.

Clinical pathology

  • The clinical pathology laboratory is equipped with automated equipment that enables us to deliver quality and consistent results even in low volumes of samples for various pre-clinical studies.
  • The quality of each instrument is ensured by instrument calibration & regular quality checks.

Tico

  • A dedicated area with controlled access for test item control to ensure safe receipt, storage and issuance of test samples as per in-house SOPs.
  • Test items are identified with unique codes and stored at environmentally controlled temperatures.
  • TICO has the facility to store compounds ranging from room temperature to ultra-low temperature.
  • Test item inventory is maintained & documented for quantity check starting from receipt in the facility till expiry/disposal/return to sponsors.

Necropsy & Histopathology area

  • We have dedicated necropsy and histopathology laboratory areas for gross and microscopic evaluation of tissues collected from various Pre-Clinical studies.
  • The laboratory has well-trained and experienced veterinary pathologists & Indian board-certified toxicological pathologist (DIBTP) to execute the pathology laboratory operations.
    • The laboratory has various well-established staining procedures for routine H&E, Immunohistochemistry, immunofluorescence and other special staining procedures.

Microbiology

  • We have a well-equipped microbiology facility for storage of microbial strains, characterization of strains, their revival and performance of experiments.
  • This lab also supports microbiological analysis of feed, water and animals’ sample for health monitoring
  • Facility for experimentation using ELISA / spectroscopy, DNA quantification / qPCR, etc.

Archival facility

  • Dry & wet archive facility to have safe archiving of study materials as per GLP norms.
  • Dedicated storage area for archival of test/reference items.
  • Entry is restricted through an electronic access card in addition to a conventional lock & key.
  • Designed to ensure minimal effect from natural disasters like fire, flood, or earthquake.

Quality Assurance

  • The quality assurance unit assesses GLP compliance in the facility through various inspections.
  • QA performs a study-based inspection to ensure GLP compliance in each study.
  • Periodically inspect each functional area of the facility (facility-based inspection) to ensure SOPs and GLP compliance.
  • Adopt risk-based inspection to ensure more involvement in studies/activities with more non-compliance.
  • Control and issuance of documents.
  • Participation in vendor qualification.
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