REGULATORY COMPLIANCE

GETTING THE RIGHT ADVICE

 

  • Compliance as an integral part of business

  • Building compliance in future Digital Health business models

  • Hybrid Compliance framework

  • Getting Infrastructure, Software Platforms, Applications to be compliant

  • Assessments, upskilling organization talent

We have expertise in:

  • Quality Management Systems

  • SOP Management

  • Conducting Internal Audits

  • Good Laboratory Practices

  • Good Manufacturing Practices

  • Management of Software applications in the organization

  • Resource management

  • GxP Compliance

  • Gap Analysis

  • Safety and Hygiene Management in labs

  • Laboratory Support (Resources and training)

  • Creation of organization's internal knowledge database and its effective utilization

  • Training, Addressing Warning letters

  • Filing NDA/ANDA, Submissions, e-CTD