Drug Discovery / Preclinical & Veterinary

Drug Discovery / Preclinical & Veterinary
Product Description

Ø  Drug Discovery services including IND & NDA  enabling studies, bridging studies for regulatory submissions, qualification of impurities, 505(b)(2) strategies, etc.

Ø  In-depth knowledge and expertise on various aspects of DMPK, genetoxicity, formulation science and bioanalytical (method development and validation).

Ø  We support in various stages of Drug Discovery and Development:

1.     Exploratory Toxicology Studies

2.     DMPK Studies

3.     Mammalian Toxicology

4.     Genetic Toxicology Testing

5.     Safety Pharmacology Studies

6.     Bioanalytical


Ø  The team has wide experience working on different routes of administration viz. Oral, Sublingual, Intravenous, Ocular, Dermal, Subcutaneous, Inhalation, Intranasal, etc.

Ø  Species handle: Mice, Rats, Rabbits, Dogs, Minipigs, Guinea Pigs, Cattle, Goat, Sheep, etc.

Ø  Well-equipped In Vitro Cell culture and microbiology laboratory.
Ø  The team has experienced working on various Veterinary Bioequivalence studies in different animal species.

Ø  Pharmacokinetic studies includes various ADME model and studies on different routes of administration.

Ø  We are following the CPCSEA (Committee for the Purpose of Control and Supervision of Experiments on Animals), FELASA (Federation of European Laboratory Animal Association) and AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care) practices for conducting studies.

Ø  Hands on experience with CVM and NADA regulations.

mKnal Global Solutions

  • IN
  • 2022
    On CPHI since
  • 1 - 24
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Pharmaceutical company
Primary activities
Pharmaceutical Company (generic finished products)

mKnal Global Solutions

  • IN
  • 2022
    On CPHI since
  • 1 - 24
    Employees
Company types
CMO/CDMO
Consultancy
Contract Research Organisation (CRO)
Contract Service
Generics/Biosimilars Manufacturer
Manufacturer/Innovator
Pharmaceutical company
Primary activities
Pharmaceutical Company (generic finished products)

More Products from mKnal Global Solutions (2)

  • Clinical Development

    Product Clinical Development

    1. Complete Project and Clinical Management of biostudy.

    2. Capacity Assessment and Qualification of CROs.

    3. Complete product assessment to understand complexity, clinical and regulatory challenges for successful execution.

    4. Protocol review and recommendations on study desig...
  • Formulation Development

    Product Formulation Development

    1. Experts in analytical chemistry, Pre- formulation, formulation and nutraceutical development and optimization, as well as analytical testing and development services.

    2. Extensive experience working Specialty Complex Products, Potent Products  & variety of dosage forms.

    3. Pro...

mKnal Global Solutions resources (1)

  • Brochure mKnal Global Solutions Corporate Presentation

    A global pharmaceutical consulting company engaged in providing pharmaceutical services for regulated markets viz. Europe, USA, Canada, Australia, China, etc.

    The company is actively working on Formulation Development and Contract Manufacturing including Supply chain. The companies key experience has been in the clinical development (Bioequivalence and Clinical Trial), Medical & Scientific Writing, GxP Audits and Reviews, Regulatory Services, Pre-Clinical work and Veterinary Product Development