REGULATORY AFFAIRS

Our consultants have experience in obtaining regulatory approvals for new, ethical and generic pharmaceuticals from National Health Surveillance Agency (ANVISA – Brazilian FDA) Brazil. We offer a wide variety of Regulatory services. If you are in the process of developing a product and would like to file for approval in any of the above mentioned markets, we can assist you to help compile, review and file documentation. We may also be able to direct you to an experienced vendor who will be able to assist you to file your ANDA electronically.

We also can file suitability petitions on your behalf and obtain bioequivalence recommendations in a timely fashion.

}Regulatory Affairs Submissions – Research Study Phase III or IV.

}Compile Review and File CTD Anda’s.

}Coordinate With Regulatory Authority – File Amendments if Needed.

}Product Approval – Post Approval.

Activities

vElaboration of projects (protocols), clinical files and research CRFs.

vPre-Clinical Phase Development

vLogistical control of the distribution of investigational products

vDevelopment of manual or electronic case report forms

vScientific and statistical consultancy

vSelections of Research Center Coordination and Researchers

vRegulatory process for ethic and legal approvals

vMonitoring, Coordination, Training, Management

vElaboration of final Reports, Articles and Pharmacovigilance

Medical Specialties

vCardiology

vPediatrics

vEndocrinology

vDermatology

vGynecology

vNutriology

vHematology

vInfectology

vOncology

Compatibility Assays

vPrimary Irritability

vCumulative Irritability

vDermal Sensitization

vPhototest (Photoirritation/Photosensitization)

vSoap Chamber Test

vComedogenicity

vAcceptability assays in different specialties

vAcnegenicity and Comedogenicity in use

Phase Clinical Trials

vPhase I Clinical Trials

vPhase II Clinical Trials

vPhase III Clinical Trials

vBioequivalence and Bioavailability

vToxicology and Clinical Efficacy for Registry or Registry Renewal (ANVISA)

vPhase IV – Post Registry Pharmacovigilance

We conduct clinical investigations on all steps listed by ICH/GCP for innovative or already registered substances.

}Pre-Clinical Studes

vAcute Toxicology

vChronic Toxicology

vReproductive Toxicology

vMutagenic Activity

vOncogenic Potencial

vPharmacokinetics and Animal Pharmacology

We provide out-licensing services to pharmaceutical and biotech companies. Our extensive client database will help you provide access to a worldwide market. We will be able to assist you to out-license your product in a highly regulated market or in the tier II and tier III market.

}Identify Product Need (API/ Finished Formulation/ NDDS).

 

}Identify In –Licensor Company.

 

}Approach/Initiate/Establish Contact.

 

}Negotiate Deal.

 

}Finalize Deal/In – License.

 

}Regulatory Filing/Approval.

     BRASKO PHARMA will help you identify market friendly products matching your needs and current portfolio. We will analyze and negotiate with the manufacturers on your behalf to make the product available to you as soon as possible.

We promote our clients’ strengths to potential licensors and sellers, develop deal structures and resolve perplexing issues and capably negotiate definitive agreements.

}Identify Product Need (API/ Finished Formulation/ NDDS).

}Identify Out – Licensor Company.

}Approach/Initiate/Establish Contact.

}Negotiate Deal.

}Finalize Deal/In – License.

}Regulatory Filing/Approval.

BRASKO PHARMA acts as a liaison between pharmaceutical companies around the world who are looking for professional assistance in Licensing of products. Our client list includes major Brazil Pharmaceutical companies, biotech and veterinary companies.

If you are a pharmaceutical or a biotech company based anywhere across the globe and looking for a Marketing partner who can successfully market your product in the Brazil market, we will be more than happy to assist you in finding you the right partner. We also provide technical consultation to Brazil.

BRASKO PHARMA is a one-stop solution for all your Pharmaceutical business needs. Our office is based in São Paulo – Brazil

BRASKO PHARMA is a specialized pharmaceutical management consulting firm serving the pharmaceutical and biotechnology industry in Brazil. We are an organized consulting company with specialized team members focusing on Product Licensing, Clinical Research and Regulatory affairs.

The members of BRASKO PHARMA are professionally qualified in their respective specialties and have served some of the major pharma companies across the globe with adequate experience in the areas mentioned above.

     BRASKO PHARMA is agents are trained and can help your company in the following areas:

}Technology Export (Licensing-Out).

}Technology Import (Licensing-In).

}Product Import.

}Product Export.

}APIs

}Joint R&D Works...

}Analytical Support

}CRO – Contract Research Organization.

}Regulatory compliance

     We believe that knowledge is the currency of the future and always aim towards creating a synergy between profitable economics and intelligent research and development.

The worldwide market for medicines is expected to exceed $1 Trillion by 2020. The emergence of global pharmaceutical companies from India, China, Brazil, Mexico and some Eastern European countries will drive the pharmaceutical industry to new horizon.  The increase in the number of companies not only increases competition in the market but may also change the way the pharmaceutical business is conducted around the world. As companies around the world strive to achieve positive growth, it will become increasingly difficult for them to create profits because of the stringent regulations, skyrocketing marketing and operational costs, availability of skilled force and ever-increasing generic competition.

Company: Location

 

}Office in Brazil

}Rua Ribeiro de Lima, 453 – Block D – Conj. 112

}Bom Retiro – ZIP 01122-000

}São Paulo – S.P. – Brazil

}Phone: 55 11 3221 1520

}Mobile: 55 11 7151 4474

}E-mail: braskopharma@gmail.com

}Skype: sambabrazil1