Get Formulario F Biof 02.doc

Filling out the FORMULARIO F BIOF 02.doc is a critical step in seeking authorization for conducting a bioavailability/equivalence study. This guide provides clear and user-friendly instructions to help users complete the form accurately and efficiently.

Follow the steps to successfully complete the FORMULARIO F BIOF 02.doc online.

1. Press the 'Get Form' button to obtain the form and open it in your document editor.
2. Enter the solicitud number and date in the designated fields at the top of the form.
3. Fill in the arancel code and payment receipt number as required.
4. Specify the sponsor's information, including their name and details pertaining to the protocol title and identification number.
5. Provide the proposed start and end dates of the study as outlined in the timeline.
6. Complete the applicant background section with legal entity name, tax number (RUT), entity type (such as pharmaceutical laboratory or representative), and legal address, ensuring to include street name, number, region, municipality, city, postal code, country, phone, fax, and email.
7. Fill in the accredited pharmacist's technical address and contact information. Include their name, specialty, and academic qualifications.
8. Provide details for the accredited medical director, including name, specialty, and qualifications.
9. Indicate the name of the legal representative or proxy who will sign the request, along with their profession and type and number of identification document.
10. In the activities section, mark whether activities are carried out or subcontracted for each clinical, bioanalytical, and statistical stage as appropriate.
11. Identify authorized centers where the clinical study will occur, providing necessary details such as center name, representative legal name, and complete contact information.
12. Compile and attach all required documentation as outlined in the form, ensuring to include authorization letters, payment confirmations, legal agreements, and ethical approvals.
13. Review the completed form for accuracy and clarity before saving or exporting the final version.
14. After saving your changes, you have the options to download, print, or share the completed form as necessary.

Take the next step and complete the FORMULARIO F BIOF 02.doc online to proceed with your study authorization.