• SSCP for Devices: Challenges and Approach

    25 November 2019 EU MDR
    As per EU MDR, for class III and implantable devices (other than custom-made or investigational ...
  • 6 Best Practices to Navigate and Sustain Regulatory Labeling Compliance

    18 November 2019 Labeling
    Regulatory Labeling It has always been a difficult task to be compliant with the changing ...
  • RAPS – 2019 Regulatory Convergence Round-up by MakroCare

    3 October 2019 EU MDR
    Recently concluded RAPS- 2019 regulatory convergence at Philadelphia, PA was attended by a good ...
  • Deadline Extended for DMF Type III eCTD Submissions by FDA

    29 August 2019 eCTD
    This being the third time in a row, the United States Food and Drug Administration (USFDA) has ...
  • Regulatory CMC Changes for Pharmaceutical Products

    7 August 2019 CMC
    All the biopharmaceutical companies must follow respective nation’s laws or regulations in order ...
  • Post-Market Surveillance Planning and Challenges under EU MDR

    11 July 2019 EU MDR
    PMS is a collection of processes and activities used to monitor the performance of a medical ...
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