DISCOVERY | RESEARCH | MONITOR | DATA SAFETY
Serious Adverse Event (SAE) / Suspected Unexpected Serious Adverse Reaction (SUSAR) management
Adverse Event (AE) data intake
Secure, accurate, and timely case entry and evaluation into validated safety databases
Coding (MedDRA, WHO Drug)
Annual safety reports and Development Safety Update Reports (DSURs)
Regulatory Support and Intelligence
Literature Search Services
Safety Medical Writing
Medical Information Support
In Country ServicesSynergy is focused on providing foreign pharmaceutical companies with the services they need to successfully enter the U.S. market...
PreClinical - NonClinicalDesign & management of preclinical programs. Preclinical Toxicology and Pharmacology consulting expertise and management. Pre-...
Clinical AffairsPre-IND Program Evaluation and Development, Clinical Development Planning, Pre-IND meetings, IND services and filings, Phase
Regulatory AffairsPre-IND / Pre-IDE regulatory services through NDA / PMA approval, the level of regulatory guidance Synergy Research
Medical Device Strategy/ArchitectureDevice development strategies, plan & implementation architecture. Creative solutions for 510(K), PMA, IDE, De Novo, Predicate...
Animal Health Care Product Dev.R&D programs for domestic animal health care products, farm and food animal programs, FDA/USDA regulated programs; INAD-NADA...
Data Management Statistics AnalysisData management, data entry, database programming, drug coding, MedDRA coding, CRF design, statistical design and analysis,
Rx-to-OTC Switch ProgramsRx-to-OTC switches: full switch (NDA supplement), partial switch (new NDA); OTC NDA, OTC Drug Monograph, Label Comprehension Studi...
Workshops & LecturesSynergy Research conducts frequent seminars and workshops for the life science industry. Below please find our current calendar
Data Monitoring CommitteesTurnkey DMC / DSMB Create an on-the-fly DMC, staffed by your selecting appropriate committee members from our extensive and exper...
Patient RegistriesPatient Registries offer unique and creative solutions in a pre and post launch environment. Used for the collection of observati...
Pharmacoeconomics/Outcomes ResearchOutcomes Research
Research programs designed for cost-benefit and economic issues relating to clinical use of drugs and devices, and therapeutic or...
Regulatory Guidances Around the WorlDA: Guidances, Code of Federal Regulations, MAPP, GLP, GMP, GCP, ICH. ICH: Guidelines; Q; Quality Topics. S; Safety Topics. E;...
Licensing, JVs, PartnershipsLeveraging our in-house strengths in drug & device strategic development, we bring together partners in a tri-partite fashion
Europe & AsiaExperience via our US staff, or working with our European and Asian partners / contract consultants, our reach extends globally....
Search a comprehensive database of thousands of FDA Inquiries.
Includes correspondence, dates, and more.