Helping pharmaceutical companies to register medicines ethically, safely and transparently for almost 20 years.
Why Wissen
A reference in research and bioequivalence studies for the pharmaceutical industry, Wissen Consultores is a group of former consultants from the ANVISA Bioequivalence Unit who have worked in the area of bioequivalence since 2003, with extensive technical and regulatory knowledge of the Brazilian pharmaceutical market.
With our clients, we build a reliable path to drug approval through technical and scientific consulting, preventing frustration and delays in the launch of a new drug.
What is a bioequivalence study?
A bioequivalence study is a comparative study conducted in humans that determines whether two formulations, such as a generic and a reference drug, have the same rate and extent of absorption in the body when administered under the same conditions. This helps to ensure that the test drug is therapeutically equivalent to the reference drug.
Step by step in the drug registration journey
Mapping
Adaptation
Connection
Approval
Services
- Preparation and/or evaluation of protocols
- Evaluation of dissolution profiles
- Monitoring of clinical and/or analytical stages
- Evaluation of reports of bioequivalence studies of Generic, Similar, New Drugs, Innovative and Biological Drugs
- Preparation of addendums to studies submitted to ANVISA
- Assistance or Preparation of responses to ANVISA requirements
- Assistance in the certification of bioequivalence centers.
- Qualification of bioequivalence centers
- Representation of International Bioequivalence Centers before ANVISA
- Check list of RE 895/2003 for pharmacokinetic and/or bioequivalence study reports
- Customization of statistical report, according to ANVISA Model
- Adaptation of Excel spreadsheets, according to ANVISA Model
- Assembly of dossier addendum for submission to CETER
- Preparation of rationale for drug registration
- Participation in Technical Meetings with ANVISA
- Preparation or evaluation of biowaiver reports by the Biopharmaceutical Classification System
- Training and Lectures
- Preparation of responses to ANVISA requirements
Mission
To act as a reliable intermediary that promotes transparency and structuring of information, facilitating communication between the pharmaceutical industry, research centers and the regulatory agencies.
Vision
We want to leave a reliable legacy for pharmacokinetic studies used in drug registration, promoting best practices and facilitating communication with pharmaceutical industries.
Values
We are driven by a passion for pharmaceutical sciences, and we act with integrity, transparency and ethics to ensure the best possible development of projects.
Who we are
Paula Macedo Cerqueira
Master's and PhD in Pharmacokinetics from USP and former technical consultant for ANVISA
Pharmacist-biochemist graduated from the Faculty of Pharmaceutical Sciences of Ribeirão Preto at the University of São Paulo – USP. Master's degree in Pharmacokinetics, including development and validation of chiral methods for analysis of drugs in biological fluids by HPLC – Faculty of Pharmaceutical Sciences of Ribeirão Preto – USP and PhD in Toxicology and Toxicological Analysis, including pharmacokinetic and pharmacogenetic analysis – Faculty of Pharmaceutical Sciences – USP. She was a technical consultant for the National Health Surveillance Agency – ANVISA (2003-2006) in the Unit for Evaluation of Relative Bioavailability/Bioequivalence Studies for generic drugs, similar drugs and new products.
She worked for 6 months on the project “Definition of the active site of CYP2D6 – use of debrisoquine as a marker drug” – University of Sheffield – England.
As the cofounder of Wissen, she has been giving technical consultancy for pharmacokinetic studies, participating in hundreds of projects for the registration of new drugs, innovator, biological, generic and similar drugs in Brazil since 2006.
Paulo Vinícius B Gonçalves
Master's and PhD in Pharmacokinetics from USP and former technical consultant for ANVISA
Pharmacist-biochemist graduated from the Faculty of Pharmaceutical Sciences of Ribeirão Preto at the University of São Paulo – USP. Master's and PhD in Pharmacokinetics of Medications in pregnant women and in development and validation of analytical methods by HPLC for quantification of drugs in biological fluids (plasma, urine, amniotic fluid and breast milk) from the Faculty of Pharmaceutical Sciences of Ribeirão Preto – USP.
He was a technical consultant for the National Health Surveillance Agency-ANVISA (2003-2006) in the Unit for Evaluation of Relative Bioavailability/Bioequivalence Studies for generic drugs, similar drugs and new products.
As the cofounder of Wissen, he has offered technical consultancy for pharmacokinetic studies, participating in hundreds of projects for the registration of new drugs, innovator, biological, generic and similar drugs in Brazil since 2006.
Contact us
- Rua Itapicuru, 369, sala 1005 - Perdizes, São Paulo -SP CEP: 05.006-000
- 55 11 2738-5969
55 11 2738-5968