Get in Touch

Edit Template


Regulatory Affairs

At Althian, we offer a comprehensive range of Regulatory Affairs services to ensure compliance and success in the complex landscape of pharmaceutical and medical device regulations.

Our experienced team is committed to delivering high-quality regulatory solutions tailored to meet your specific needs. Contact us today to learn more about how we can help navigate the regulatory landscape and achieve regulatory compliance efficiently.

  • New Drug Application (NDA) Preparation and Submissions
  • Regulatory Strategy Development and Consulting
  • Regulatory Intelligence and Research
  • Product Registration and Marketing Authorization
  • Preparation and Submission of Regulatory Dossiers
  • Clinical Trial Application and Authorization
  • Regulatory Compliance Assessment and Gap Analysis
  • Labeling and Package Insert Review and Development
  • Pharmacovigilance and Adverse Event Reporting
  • Post-Marketing Surveillance and Compliance Monitoring
  • Import/Export Permits and Licenses
  • Regulatory Document Translation and Localization
  • Due Diligence Assessments for Regulatory Compliance
  • Regulatory Advocacy and Representation with Health Authorities
  • Registration and Approval of Medical Devices
  • Regulatory Training and Workshops
  • Assistance with Regulatory Inspections and Audits
  • Changes and Variations to Product Registrations
  • Renewal and Maintenance of Marketing Authorizations
  • Regulatory Support for Clinical Trial Imports and Exports
  • Regulatory Support for Controlled Substances and Narcotics
  • Development of Local Manufacturing and Distribution Strategies
  • Assistance with Regulatory Queries and Responses
  • Harmonization with International Regulatory Standards
  • Development of Standard Operating Procedures (SOPs) for Regulatory Processes
  • Compliance with Good Clinical Practice (GCP) Guidelines

Partner with Althian for reliable, efficient, and compliant clinical research services in Mexico. Contact us today to discuss your specific needs and start your journey towards successful clinical trials.

Expertise and commitment to excellence

Look no further than Althian, a leading company specializing in a wide range of clinical research services.

Clinical research solutions


Clinical Trial Services

Regulatory Affairs

Data Management and Analysis

Pharmacovigilance and Drug Safety

Other Services


Contact Us




Privacy Policy




Reliable and experienced partner in clinical research

You have been successfully Subscribed! Ops! Something went wrong, please try again.
© 2023 Created with Royal Elementor Addons