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OUR SERVICES

Our experienced staff and network will provide the support your need. Our aim is to acquire speedy approvals to enable clients to achieve their objective of a timely and successful product launch

We provide the following regulatory requirement services:        

 

  • Specialized in Import license of Medical Devices & Diagnostic Kits/reagents, both critical and non – critical invitro diagnostic kits / reagents

 

  • Specialized in Manufacturing license of Medical Devices & Diagnostic Kits/reagents, both critical and non – critical invitro diagnostic kits/reagents

 

  • Specialized in Auditing Medical device & IVD manufacturing units for compliance with GMP norms and other regulatory norms as per the MDR 2017.

 

  • Specialized in Architectural designing of Manufacturing units.

 

  • Specialized in Architectural designing of Microbiology labs.

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  • Facilitate in preparation of Documentation

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  • Standard operation procedures,

    • Warehouse

    • Dispensing and Sampling

    • Manufacturing

    • Quality control

    • Maintenance dept.

    • Quality Assurance

    • Equipments of manufacturing & Quality control.

    • Microbiology

    • Others…

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  • Standard testing procedures.

  • Validation of process and analytical methods

  • Stability studies

  • Bio-compatibility

  • Training

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Regulatory strategy
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Plan for product classification, regulatory pathway selection, technical documentation, and quality management.

 

Clinical research
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Assess clinical data requirements for your device and design a clinical strategy that supports your commercialization and product goals.

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Technical file & dossier development
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Get expert help compiling technical and design documentation tailored to requirements for Indian regulatory clearance and access to Indian markets.

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