Evaluation to identify adequacy with regulatory rules
⦁ Bioequivalence studies;
⦁ Documentation for submission of drug registration (regulatory and / or technical evaluation);
⦁ Clinical research protocols;
⦁ Bioequivalence protocols;
⦁ Statistics of clinical studies and bioequivalence conducted in Brazil and abroad.
Consulting, technical and regulatory advice
⦁ Definition of strategy and regulatory support for registration and post-registration of drugs in Latin America (especially Brazil) and Europe;
⦁ Meeting the requirements;
⦁ Technical defense at ANVISA.
Elaboration of technical-scientific contents
⦁ Scientific writing (scientific publications, research projects, medical-scientific communication for marketing);
⦁ Writing of drugs patents;
⦁ Investigator´s brochure;
⦁ Clinical research protocols;
⦁ Bioequivalence study protocols;
⦁ DDCM - Clinical Drug Development Dossier;
⦁ Dossier for evaluation of probiotics for use in food;
⦁ Technical and scientific reports:
- Efficacy and safety;
- Linear pharmacokinetics for biowaver;
- Pharmacokinetic and pharmacodynamic interactions;
- Non-clinical studies of toxicity and efficacy;
- Food supplements.
⦁ Writing of labels.
Monitoring in pharmaceutical bioequivalence studies
New Phartrials service Monitoring in pharmaceutical bioequivalence studies Qualified to perform monitoring in accordance with Good Clinical Practice (ICH - GCP) and in accordance with own SOPs (Standard Operating Procedures), ensuring that the clinical study is conducted, registered and reported in accordance with the clinical protocol.
Innovation
Research in scientific literature for:
⦁ New associations with therapeutic potential;
⦁ New therapeutic indications;
⦁ More effective drug release technologies than existing ones.
Evaluation to identify adequacy with regulatory rules
⦁ Bioequivalence studies;
⦁ Documentation for submission of drug registration (regulatory and / or technical evaluation;.
⦁ Clinical research protocols;
⦁ Bioequivalence protocols;
⦁ Statistics of clinical studies and bioequivalence conducted in Brazil and abroad.
Consulting, technical and regulatory advice
⦁ Definition of strategy and regulatory support for registration and post-registration of drugs in Latin America (especially Brazil) and Europe;
⦁ Meeting the requirements.
⦁ Technical defense at ANVISA.
Elaboration of technical-scientific contents
⦁ Scientific writing (scientific publications, research projects, medical-scientific communication for marketing);
⦁ Writing of drugs patents;
⦁ Investigator´s brochure;
⦁ Clinical research protocols;
⦁ Bioequivalence study protocols;
⦁ DDCM - Clinical Drug Development Dossier;
⦁ Dossier for evaluation of probiotics for use in food;
⦁ Technical and scientific reports:
- Efficacy and safety;
- Linear pharmacokinetics for biowaver;
- Pharmacokinetic and pharmacodynamic interactions;
- Non-clinical studies of toxicity and efficacy;
- Food supplements.
⦁ Writing of labels.
Monitoring in pharmaceutical bioequivalence studies
New Phartrials service Monitoring in pharmaceutical bioequivalence studies Qualified to perform monitoring in accordance with Good Clinical Practice (ICH - GCP) and in accordance with own SOPs (Standard Operating Procedures), ensuring that the clinical study is conducted, registered and reported in accordance with the clinical protocol.
Innovation
Research in scientific literature for:
⦁ New associations with therapeutic potential;
⦁ New therapeutic indications;
⦁ More effective drug release technologies than existing ones.
