Developing a sound regulatory strategy, in-depth understanding of the country or region-specific regulatory requirements for specific product categories, along with accurate interpretations, implications, and applicability of such regulations, are instrumental in achieving a global outreach for medical products. Whether the product is a medical device, diagnostics, biologics, or a pharmaceutical drug, a careful consideration of the regulatory strategy early on is crucial for securing timely clearances or approvals.  

ACL Digital Life Sciences Regulatory Services include expert consultation in building a robust global Regulatory strategy, support in executing the strategy, which can range from early engagement with Health Authorities, agencies or Notified Bodies to Regulatory filings and response to RFIs.

Regulatory Affairs
Infographic 1468X523 Regulatory Affairs

 

  • Regulatory Consulting

    • IDMP / Consulting
    • Regulatory Post Market Compliance Support
    • IVDR Consulting
    • Strategic Support for Successful Submission 
    • Regulatory Intelligence
    • Medical Device Consulting
    • Handling Queries from Health Authorities
  • Regulatory Writing for Pharmaceuticals

    • Clinical Overviews (eCTD Module 2.5)
    • Clinical Summaries (eCTD Module 2.7)
    • Clinical Study Report (eCTD Module 5)
    • Strategic Labelling, Publishing
    • Protocols, ICF, Case Record Forms
  • Regulatory Writing for Medical Devices

    • EU MDR Gap Analysis
    • UDI Consulting
    • CER / CEP Writing
    • Post Market Surveillance
    • Post Clinical Follow Up Activities