• Viability, risk evaluations, feasibility and strategic planning.

• Selection of site(s) and investigators.

• Management of investigators and site contracts.

• Clinical trial management plan.

• Regulatory consulting and strategy.

• Translation of study documents.

• Regulatory document management.

• Ethics committee/IRB submissions.

• IND and CTA submissions to the RA.

Document management and Logistics (Ethics Committee, IRB/Regulatory Agencies):

• Investigation product, laboratory supplies and equipment; medical devices importation and exportation of biological samples.

• Management of storage and distribution of study material.

• Site training and support.

• Investigator meeting organization.

• Project management and oversight.

• Clinical supplies and drug management.

• Clinical monitoring and permanent assistance site management.

• Pharmacovigilance.

• Periodic safety and study progress reports.

• Scientific article writing & publishing strategies​.

• Bibliographic reviews​.

• Scientific presentations creation​.

• Poster preparation​.

• Medical translations.

• Adverse event reporting and management​.

• Safety monitoring and pharmacovigilance activities.

• Periodic reports to Health Authorities.

• Permanent internal audits according to regulatory standards.

• Supervision of SOPs application and updating according to regulatory standards.

• Risk management.

• Support during external audits.

• GCP audits.

• Risk management planning and assessment.

• Regulatory advising expertise​.

• Efficient dossier management​.

• Comprehensive documentation support​.

• Tailored regulatory strategy development​.

• Ongoing compliance assistance.