Regulatory Services 

Regulatory Strategy and Planning: Developing regulatory strategies tailored to specific products and markets, including identifying the most efficient regulatory pathways. 

Regulatory Submissions: Preparing and submitting regulatory documents such as Investigational New Drug (IND) applications, New Drug Applications (NDA), Biologics License Applications (BLA), Medical Device Submissions (510(k), PMA), and Marketing Authorization Applications (MAA). For all the LATAM countries. 

Regulatory Intelligence: Monitoring and interpreting regulatory changes and trends to provide clients with up-to-date information on regulatory requirements. 

Clinical Trial Support: Providing regulatory support for clinical trials, including protocol development, clinical trial applications (CTAs), and interactions with regulatory authorities. 

Labeling and Packaging Review: Ensuring that product labeling and packaging meet regulatory requirements, including content, format, and language. 

Regulatory Affairs Outsourcing: Providing ongoing or project-based regulatory affairs support, including acting as an interim regulatory affairs department. 

Regulatory Due Diligence: Conducting regulatory due diligence for mergers and acquisitions to assess regulatory risks and compliance status. 

Product Classification and Registration: Assisting with the classification of products and obtaining necessary registrations and approvals for different markets.