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We have experience with Synthetic, Biological and Herbal Medicines, Health Products, Advanced Cell Therapy, Vaccines, Cosmetics and Food. For products that require Phase I, II, III clinical study or post-Marketing / Phase IV Clinical Study studies, we offer:


  • For innovative products or for product that will need Clinical Research for registration;

  • Product classification according to the different regulated areas of ANVISA;

  • Clinical Rationale and legal scope development that the product must meet with regulatory authorities;

  • Therapeutic Experimentation Report development;

  • Dossier preparation for drugs and health products (DDCM and DICD for ANVISA);

  • Requesting meetings with ANVISA to discuss the best regulatory strategy for the product;

  • Support for product registration in other countries (FDA, EMA, ANMAT, INVIMA and other agencies).


  • Study Protocol development;

  • Clinical Investigation Plan;

  • Investigator’s Brochure;

  • Informed Consent Forms and Patient Information;

  • Laboratory Manuals;

  • Clinical Study Report;



  • Qualification of Vendors (partners for the different stages of the project);

  •  Startup of studies (feasibility, qualification and initiation of research centers);

  • Support for ethical approvals (CEP and CONEP);

  • Import of Investigational Product and others;

  • Management of study drugs;

  • Training in Good Clinical Practices;

  • Blanck CRF design support;

  • Meeting of Investigators;

  • Initiation Visit;

  • Training and Retraining;

  • Monitoring Plan;

  • Monitoring (initiation, routine, administrative monitoring, pharmaceutical monitoring, medical monitoring, retraining, closing);

  • Project Management Plan;

  • Inclusion Management (FPI–LPI);

  • Management plan for deviations, violations, misconduct and fraud during the clinical trial.

  • Control of regulatory reports (ECs, CONEP and ANVISA);

  • Blind and non-blind team;

  • CRO and Sponsor Responsibilities Plan;

  • SAE management. and Pharmacovigilance;

  • Data Management;

  • Medical Coding;

  • Certified team for e-CRF building (REDCap and IBM platforms)

  • Quality audits;



  • Qualified professional in clinical trial for capture, management and evaluation of Serious Adverse Events.

  • Case Narrative Writing for Reporting Adverse Events.

  • MedDRA coding.

  • Medical review and evaluation of safety information.

  • Elaboration of notification of suspected unexpected serious adverse reaction.

  • Individual case security information notification.

  • Preparation and submission of Periodic Safety Reports (PSUR, DSUR).

  • Azidus has procedures for performing the activities or we can use the sponsor's SOPs.



  • Development of systems and processes that ensure that all adverse events are properly collected and reported.

  • Regular preparation of Periodic Pharmacovigilance Reports and submission of adverse events to Health Authorities.

  • Continuous monitoring of the safety profile of approved drugs, including signal detection, its assessment, alerts to the need to update package inserts and update regulatory information.

  • Routine Risk Minimization Activities: Activities developed to warn and inform about an adverse event, with the objective of reducing the probability of its occurrence.

  • Treatment of Previously Unknown Critical Information: information about the safety of a drug that is not available at the time of registration and that represents a limitation of safety data.


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