Evolving Regulatory Landscape

Empowering Life Sciences Firms to Meet Global Standards
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In an exceedingly interconnected and rapidly evolving regulatory space where new layers of complexities are omnipresent, our Regulatory Affairs experts provide strategic guidance and support to interface and comply with the various regulators. Our services include Regulatory Strategy and Planning, compliance, submission management and more.
Regulatory Strategy and Planning
  • Develop tailored regulatory strategies that support product development and commercialization efforts.
  • Identify regulatory requirements and potential roadblocks
  •  Identify regulatory requirements and potential roadblocks
  • Create regulatory timelines and milestones.
  • Prepare and review eCTD filings in the US, Canada, and The European Union to ensure local regulator’s requirements are met.
  • Prepare various risk assessments as per FDA/EMA/ICH requirements
  • Conduct regulatory gap analysis and implement corrective actions
  • Provide training on regulatory requirements
  • Assist you in preparing and submitting IND, NDA, BLA, and MAA with various regulatory agencies
  • Assist you in managing and interacting with regulatory agencies
  • Address Clarifaxes, comprehensive response letters and other agency requests
  • Develop compliant labeling and packaging materials
  • Review and update labeling and packaging to ensure regulatory compliance
  • Ensure consistency across global markets
  • Prepare clients for regulatory inspections
  • Conduct mock audits ad provide remediation guidance
  • Develop and implement corrective action plans
  • Track and analyze regulatory changes and updates
  • Provide alerts and impact assessments
  • Identify potential regulatory risks and opportunities
  • Develop strategic responses to regulatory changes

Clients benefit from our expertise in the pharmaceutical, medical devices, vaccines, generic and biosimilar industries through:

  • Expert guidance on regulatory requirements
  • Increased efficiency in regulatory submissions
  • Reduced risk of non-compliance
  • Strategic planning for regulatory success
  • Enhanced credibility with regulatory agencies

Learn More How Lesirg Can Provide You With a Full Suite of Regulatory Support

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