REGULATORY STRATEGY

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GAP ANALYSIS

DETAILED EVALUATION OF REGISTRATION DOSSIER ON TECHNICAL AND REGULATORY COMPLIANCE, RISK ASSESSMENT AND MITIGATION OF REQUIREMENTS.

DUE DILIGENCE

EVALUATION OF THE HISTORY OF THE MARKETING AUTHORIZATION/PRODUCT FOR ACQUISITIONS, SALES, OWNERSHIP TRANSFERENCE, CLONES AND POST-APPROVALS.

START-UPS

ROAD-MAP FOR STRART-UPS, SUPPORT FOR ACQUISITION OF SHELF-COMPANIES AND LICENSE HOSTING FOR MEDICINES.

REGULATORY AUDIT

IN COMPANY ACTIVITY, WITH THE CONTRACTOR REGULATORY TEAM, TO ASSESS THE ORGANIZATION, ARCHIVING AND TRACKING SYSTEM FOR MARKETING AUTHORIZATION DOSSIERS, MAPPING OF COMMON QUERIES, APRs, RENEWALS AND POST-APPROVALS, IDENTIFICATION OF RISKS, INCONSISTENCIES AND SUPPORT IN RISK MITIGATION.

CLINICAL STRATEGY

SUPPORT FOR THE CONFECTION AND APPROVAL OF DDCMs, DEECs AND CLINICAL STRATEGY FOR REGISTRATION OF DRUG PRODUCTS AT BRAZIL.

PORTFOLIO ASSESSMENT

IDENTIFICATION OF REGULATORY SCENARIO, COMPETITORS, HORIZON OF APPROVAL AND PRIORITIZATION STRATEGIES.

“However beautiful the strategy, you should occasionally look at the results.”

Winston Churchill

Address:

WT Morumbi 

Av. das Nações Unidas, 14261 - Ala B

25° andar - São Paulo / SP

Phone:

(+55 11) 99420-1726 / (+55 11) 99483-0623

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