TRAINING & CAPACITATION

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

Steve Jobs

REGULATORY STRATEGY

Marketing Authorization application for synthetic and semi-synthetic drugs.

Techniques and concepts to improve the quality of dossiers submitted to ANVISA and speed up approvals.

BIOLOGIC 

PRODUCTS

New Biological Products

and Biosimilars:

regulatory concepts, techniques and strategies to improve the efficiency of M.A. submission and post-approval applications.

ANALYTICAL VALIDATION

A regulatory analysis.

Techniques for the regulatory evaluation of analytical method validation reports and strategies to mitigate queries at M.A. application and post-approval variations.

POST APPROVAL

VARIATIONS

Classification, Risk Analysis

and PATE.

Understanding the mechanism and preparing the team for the submission and approval of  post-approval variations of synthetic and semi-synthetic drugs.

 CTD

DOSSIERS

Guide 24/2017.

Regional requirements.

Concepts and techniques for evaluating, preparing, assembling and converting M.A. application and post-approval variations dossiers. 

PROCESS VALIDATION

Guide 01/2015.

Techniques for regulatory assessment of process validation reports and preparation of the validation summary.

STABILITY &  DEGRADATION

RDC 318/2019 and RDC 53/2015

Technical requirements and applicability.

How to evaluate reports and justifications from regulatory point of view.

 

APIs

DIFA & CADIFA

RDC 359/2020 and  361/2020

New regulatory pathways for active pharmaceutical ingredients

Evaluation of DMFs,

risk mapping and strategies for regulatory submission.

Address:

WT Morumbi 

Av. das Nações Unidas, 14261 - Block A

São Paulo / SP

BRAZIL

Phone:

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

  • LinkedIn Social Icon
  • Instagram Brainlike