PHARMAREGIS CONSULTORIA

ABOUT US

PHARMAREGIS is a consultancy founded in 2014 that acts in regulatory affairs, drug pricing, clinical/nonclinical and business development.


We offer support to local and international customers in Portuguese, English and Spanish.

Marisa Ohba, founder of PHARMAREGIS, has degree in Pharmacy-Biochemistry from the University of São Paulo (USP),  Master's degree in Business Administration from the Getúlio Vargas Foundation (FGV) and MBA in Healthcare Management from the Federal University of São Paulo (UNIFESP).


Extensive experience in pharmaceutical industry and consulting, including company startups, drug registration, drug price approval, clinical/preclinical testing, and business development.

SERVICES

REGULATORY AFFAIRS - Drug

  • Gap Analysis of drug registration
  • Drug registration dossier
  • Regulatory strategy
  • ANVISA Good Manufacturing Practice certification
  • ANVISA Good Practice certification for international bioequivalence center

REGULATORY AFFAIRS - Active Pharmaceutical Ingredient (API)

  • DIFA/DMF Gap Analysis
  • CADIFA application request
  • ANVISA Good Manufacturing Practice certification
  • Support for foreign API manufacturer at ANVISA

CLINICAL & NONCLINICAL

  • Elaboration of Technical-Scientific Opinion (PTC)
  • Elaboration of Safety & Efficacy Report
  • Gap Analysis of clinical and nonclinical studies

DRUG PRICING

  • Price definition strategy
  • Elaboration of Price Information Document (DIP)

BUSINESS DEVELOPMENT

  • Support for companies in identifying partners for product representation
  • Support for companies in identifying Brazilian company to host their products
  • Support in acquiring Brazilian regularized company

CONTACT

Contact us

Contact PHARMAREGIS filling the fields or emailing to: contato@pharmaregisconsultoria.com.br

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