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.