Regulatory Affairs

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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.

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