Centralized Regulatory Contact

• Acting as the official representative for sponsors and CROs in all communications with health authorities.

• Managing correspondence, submission tracking, and document delivery to ensure timely and compliant interactions.

• Coordinating with ethics committees and institutional review boards when required.

Query & Deficiency Management

• Handling regulatory queries, clarification requests, and deficiency letters with speed and accuracy.

• Preparing and submitting formal responses, additional documentation, and corrective actions as needed.

• Advising on the regulatory impact of deficiencies and guiding resolution strategies to avoid delays or rejections.

Follow-Up & Approval Acceleration

• Monitoring submission status and proactively engaging with agencies to expedite review timelines.

• Scheduling and supporting pre-submission meetings, technical consultations, and post-submission follow-ups.

• Maintaining transparent communication with sponsors throughout the approval process.

Regional Coordination Across LATAM

• Navigating regulatory nuances across multiple countries to ensure consistent messaging and documentation.

• Supporting multi-country submissions with harmonized communication strategies.

• Translating and adapting responses for Spanish- and Portuguese-speaking authorities.