Clinical Development

Clinical Development
Product Description

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 design, statistical approaches and sample size determination

5. Provide Technical and Scientific rationale for overcoming Regulatory hurdles.

6. Successful Execution and Management of Para IV (First To File)
Biowaiver Approaches.


7. Monitoring and Quality Assurance of Clinical Data.

8. Bioanalytical Audits and Data Verification of MD/MV & Bioanalysis.

9. Review and Compliance of Clinical Reports.

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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)
View company profile
Categories
more categories Show less

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)
View company profile

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mKnal Global Solutions resources (1)

  • mKnal Global Solutions Corporate Presentation

    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