Complete and modular solutions (Phases I to IV)
The largest analytical park in Latin America for mass spectrometry
Our Contract Research Organization (CRO) brings together more than 20 years of experience and relationships with over 200 pharmaceutical companies, providing comprehensive support in clinical studies and regulatory operations in Brazil.
Full-service portfolio
Full-service portfolio
Full-service portfolio
Full-service portfolio
Modular and personalized approach
Modular and personalized approach
Modular and personalized approach
Modular and personalized approach
+20 years
+20 years
of experience
+200
+200
global sponsors
Structured solutions for conducting clinical studies
Structured services to meet operational, scientific, and regulatory demands, ensuring methodological accuracy and international compliance.
Scientific Consulting & Project Feasibility
Strategic planning and assessment of technical, regulatory, and operational feasibility for efficient clinical studies that adhere to global best practices.
Regulatory Matters & Ethical Dossier
Elementary Impurities
Nitrite (in excipient)
Nitrosamines (Phase I and II)
Extractable and Leachable (Phase I and II)
Medical Writing & Scientific Documentation
Characterization of Substances
Particle Size and Morphology
Polymorphism
Organic Prediction and Forced Degradation
Study Start-up
Cleaning Validation
Process Validation
Compatibility
Supplements (Vitamins and Minerals)
Scientific Consulting & Project Feasibility
Strategic planning and assessment of technical, regulatory, and operational feasibility for efficient clinical studies that adhere to global best practices.
Regulatory Matters & Ethical Dossier
Elementary Impurities
Nitrite (in excipient)
Nitrosamines (Phase I and II)
Extractable and Leachable (Phase I and II)
Medical Writing & Scientific Documentation
Characterization of Substances
Particle Size and Morphology
Polymorphism
Organic Prediction and Forced Degradation
Study Start-up
Cleaning Validation
Process Validation
Compatibility
Supplements (Vitamins and Minerals)
Scientific Consulting & Project Feasibility
Strategic planning and assessment of technical, regulatory, and operational feasibility for efficient clinical studies that adhere to global best practices.
Regulatory Matters & Ethical Dossier
Elementary Impurities
Nitrite (in excipient)
Nitrosamines (Phase I and II)
Extractable and Leachable (Phase I and II)
Medical Writing & Scientific Documentation
Characterization of Substances
Particle Size and Morphology
Polymorphism
Organic Prediction and Forced Degradation
Study Start-up
Cleaning Validation
Process Validation
Compatibility
Supplements (Vitamins and Minerals)
Scientific Consulting & Project Feasibility
Strategic planning and assessment of technical, regulatory, and operational feasibility for efficient clinical studies that adhere to global best practices.
Regulatory Matters & Ethical Dossier
Elementary Impurities
Nitrite (in excipient)
Nitrosamines (Phase I and II)
Extractable and Leachable (Phase I and II)
Medical Writing & Scientific Documentation
Characterization of Substances
Particle Size and Morphology
Polymorphism
Organic Prediction and Forced Degradation
Study Start-up
Cleaning Validation
Process Validation
Compatibility
Supplements (Vitamins and Minerals)
Project Management & Clinical Monitoring
Method Development and Validation
Solubility
eCRF & Data Management
Elementary Impurities
Nitrite (in excipient)
Nitrosamines (Phase I and II)
Extractable and Leachable (Phase I and II)
Biostatistics
Characterization of Substances
Particle Size and Morphology
Polymorphism
Organic Prediction and Forced Degradation
Pharmacovigilance, Medical Affairs & Safety Committees (DSMB)
Cleaning Validation
Process Validation
Compatibility
Supplements (Vitamins and Minerals)
Project Management & Clinical Monitoring
Method Development and Validation
Deformulation
Compatibility
Solubility
eCRF & Data Management
Elementary Impurities
Nitrite (in excipient)
Nitrosamines (Phase I and II)
Extractable and Leachable (Phase I and II)
Biostatistics
Characterization of Substances
Particle Size and Morphology
Polymorphism
Organic Prediction and Forced Degradation
Pharmacovigilance, Medical Affairs & Safety Committees (DSMB)
Cleaning Validation
Process Validation
Compatibility
Supplements (Vitamins and Minerals)
Project Management & Clinical Monitoring
Method Development and Validation
Solubility
eCRF & Data Management
Elementary Impurities
Nitrite (in excipient)
Nitrosamines (Phase I and II)
Extractable and Leachable (Phase I and II)
Biostatistics
Characterization of Substances
Particle Size and Morphology
Polymorphism
Organic Prediction and Forced Degradation
Pharmacovigilance, Medical Affairs & Safety Committees (DSMB)
Cleaning Validation
Process Validation
Compatibility
Supplements (Vitamins and Minerals)
Project Management & Clinical Monitoring
Method Development and Validation
Deformulation
Compatibility
Solubility
eCRF & Data Management
Elementary Impurities
Nitrite (in excipient)
Nitrosamines (Phase I and II)
Extractable and Leachable (Phase I and II)
Biostatistics
Characterization of Substances
Particle Size and Morphology
Polymorphism
Organic Prediction and Forced Degradation
Pharmacovigilance, Medical Affairs & Safety Committees (DSMB)
Cleaning Validation
Process Validation
Compatibility
Supplements (Vitamins and Minerals)
Why conduct clinical studies in Brazil?
Brazil: regulatory speed, scientific quality, and competitive advantage
More agile regulatory deadlines in Latin America
More agile regulatory deadlines in Latin America
More agile regulatory deadlines in Latin America
More agile regulatory deadlines in Latin America
Review of pharmacokinetic data and definition of the most suitable design.
High operational performance at a competitive cost
High operational performance at a competitive cost
High operational performance at a competitive cost
High operational performance at a competitive cost
Review of previous studies and validated methodologies.
Qualified centers and frequent audits
Qualified centers and frequent audits
Qualified centers and frequent audits
Qualified centers and frequent audits
Definition of the type of study, population, and necessary tests.
Expanded access to participants and genetic diversity
Expanded access to participants and genetic diversity
Expanded access to participants and genetic diversity
Expanded access to participants and genetic diversity
Selection of analytes and validated methods according to ANVISA, EMA, and FDA.
Continuous growth of the industry and a stable regulatory environment
Continuous growth of the industry and a stable regulatory environment
Continuous growth of the industry and a stable regulatory environment
Continuous growth of the industry and a stable regulatory environment
Sample calculation and statistical rationale for robustness of results.
Integrated logistics and regulatory management
Synvia provides complete coordination of importation, storage, transportation, issuance of permits, cost analysis, and regulatory compliance for clinical studies.
SWIFT importation and complete control of materials
SWIFT importation and complete control of materials
SWIFT importation and complete control of materials
SWIFT importation and complete control of materials
Issuance of ANVISA and Federal Revenue authorizations
Issuance of ANVISA and Federal Revenue authorizations
Issuance of ANVISA and Federal Revenue authorizations
Issuance of ANVISA and Federal Revenue authorizations
Storage and monitored security
Storage and monitored security
Storage and monitored security
Storage and monitored security
Cost management and negotiations
Cost management and negotiations
Cost management and negotiations
Cost management and negotiations
Why choose Synvia
Experience, compliance, and scientific accuracy
Synvia has a successful track record in studies submitted and approved by different regulatory authorities.
Our operational model follows global quality standards, ensuring complete traceability and tri-lingual documentation.
Contact
Talk to our experts
Discover how Synvia can support your studies, analyses, and projects.
Contact
Talk to our experts
Discover how Synvia can support your studies, analyses, and projects.