Trusted partner for global pharmaceutical Companies
Clinical Development provider with strong BE/BA expertise
Experience
§ Pharma Sponsors, CROs and Research Institutes
Clients. Delivering services successfully all over the world.
Footprints
§ Operations in South America, North America
and India.
§ Plan to expand operations to China and Europe
within 2 years.
Services
§ Representative Office for international CROs
operations in Brazil;
§ Purchase-to-delivery: Exporting of pharma products
overseas for testing and analysis purposes;
§ Consulting services for sites prior to ANVISA
inspection and during ANVISA audits;
§ Feasibility P-I to P-IV Studies;
§ Feasibility PK-PD Studies;
§ Project Planning;
§ Project Management;
§ In Vitro In Vivo Correlation Analysis;
§ Dissolution Profile Evaluation;
§ Study Design and Protocol Writing;
§ BioStatistics calculation and designing;
§ Regulatory Approvals;
§ Site/Investigator Identification and
Selection;
§ Site Monitoring;
§ Site Management;
§ Quality Assurance/Audit Services;
§ Protocol to Report services;
§ Bioequivalence and Bioavailability studies;
§ Pharmacokinetic and Pharmacodynamic studies;
§ Special / Patient Population studies;
§ Food effect and Drug – Drug Interaction
studies;
§ Biowaiver Reports;
§ Training of ANVISA´s regulatory and Technical
Affairs - Online and In Company;