TRAINING & CAPACITATION

“Great things in business are never done by one person. They're done by a team of people.”

Steve Jobs

RDC 200/17

REGISTRO

01

REGULATORY STRATEGY

Regulatory and Technical Strategies to improve the quality of dossiers presented to ANVISA and accelerate approvals.

02

ANALYTICAL METHOD VALIDATION

Techniques for the regulatory evaluation of analytical validation reports and strategies for reducing queries at registration and post-approval petitions.

03

process validation

Techniques for the regulatory evaluation of process validation reports, preparation of summary as per Anvisa's templates and reduction of queries registration and post-approval petitions.

04

post-approvals & pate

Classification, Risk Analysis and preparation of PATE. Understanding the mechanism and preparing the team for the implementation and approval of requests for post-approval variations.

05

biologic products

New Biological Products and Biosimilars : concepts, techniques and regulatory strategies to improve the submission of M.A. dossiers and post-approval variations.

06

road map

Market, regulation, licenses and everything a company needs to know from the regulatory point of view to start its activities in Brazil.

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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