REGULATORY SERVICES

Feasibility:

Site Identification, obtaining information and feasibility documentation to conduct clinical trials according to the requirements of the protocol to develop.
We have immediate access and a data base of pre-qualified investigators in different therapeutic areas, eager and willing to participate in clinical studies.

Review and adaptation of the informed consent form::

Aware of the importance of this document, we conduct quality revisions against protocol and good clinical practices guidelines as well as the adaptation according to the local requirements in each Country, in order to have a final appropriate document for the submission of the study.

Coordination of translations

We participate in coordination of document translations with local certified translators, performing a revision to verifying that there is a correct translation from the point of view grammatical and linguistic.

Compilation and revision of documents of the Investigational Site

We coordinate the compilation of the required documentation for the local submission of the study, and other documents that can be requested by the client for dossier of documents to release the investigational product. All the collected documentation is reviewed in order to have it ready as needed for the corresponding regulatory processes.

Submission to Ethics Committee and Regulatory Authorities.

We do the assembly and quality control and revision of the protocol submission dossier to the local or independent Ethics Committee and Health authorities.

Question analysis

In case of questions from the Ethics Committee and evaluating Health Authorities, we analyze and set forth proposals of response to our clients.

Regulatory monitoring

We maintain a control of required reports for the Ethics committee and/or regulatory authorities such as progress reports, final reports, and annual renewals, among others.

Safety Information Notification (SUSARs, CIOMS, MEDWATCH, Etc.)

We conduct the report of safety information to the Ethics Committee and/or corresponding regulatory authorities.

Regulatory Counseling in Pharmacovigilance

We are ready to listen your concerns to provide the best regulatory counseling. Constantly updated in the local regulations, always ready to offer answer to your inquiries.