DISCOVERY | RESEARCH | MONITOR | DATA SAFETY
Pharmacovigilance Solutions
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Serious Adverse Event (SAE) / Suspected Unexpected Serious Adverse Reaction (SUSAR) management
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Adverse Event (AE) data intake
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Secure, accurate, and timely case entry and evaluation into validated safety databases
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Coding (MedDRA, WHO Drug)
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Annual safety reports and Development Safety Update Reports (DSURs)
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Medical Review
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Subject Narratives
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Regulatory Support and Intelligence
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Literature Search Services
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EudraVigilance Reporting
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Safety Medical Writing
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Medical Information Support
Services
Services
Synergy ServicesIn Country Services
Synergy is focused on providing foreign pharmaceutical companies with the services they need to successfully enter the U.S. market...PreClinical - NonClinical
Design & management of preclinical programs. Preclinical Toxicology and Pharmacology consulting expertise and management. Pre-...Clinical Affairs
Pre-IND Program Evaluation and Development, Clinical Development Planning, Pre-IND meetings, IND services and filings, PhaseRegulatory Affairs
Pre-IND / Pre-IDE regulatory services through NDA / PMA approval, the level of regulatory guidance Synergy ResearchMedical Device Strategy/Architecture
Device 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 Analysis
Data management, data entry, database programming, drug coding, MedDRA coding, CRF design, statistical design and analysis,Rx-to-OTC Switch Programs
Rx-to-OTC switches: full switch (NDA supplement), partial switch (new NDA); OTC NDA, OTC Drug Monograph, Label Comprehension Studi...Pharmacovigilance Pre Post Launch
Pharmacovigilance: Pre & Post LaunchWorkshops & Lectures
Synergy Research conducts frequent seminars and workshops for the life science industry. Below please find our current calendarData Monitoring Committees
Turnkey DMC / DSMB Create an on-the-fly DMC, staffed by your selecting appropriate committee members from our extensive and exper...Patient Registries
Patient Registries offer unique and creative solutions in a pre and post launch environment. Used for the collection of observati...Pharmacoeconomics/Outcomes Research
Outcomes ResearchResearch programs designed for cost-benefit and economic issues relating to clinical use of drugs and devices, and therapeutic or...
Regulatory Guidances Around the Worl
DA: Guidances, Code of Federal Regulations, MAPP, GLP, GMP, GCP, ICH. ICH: Guidelines; Q; Quality Topics. S; Safety Topics. E;...Licensing, JVs, Partnerships
Leveraging our in-house strengths in drug & device strategic development, we bring together partners in a tri-partite fashionEurope & Asia
Experience via our US staff, or working with our European and Asian partners / contract consultants, our reach extends globally....IPAD Clinical
iPAD comes to clinical research here, with iCLINICAL for the iPAD. Amazing Savings in Time, Quality, Cost.Show More
FDA Inquiries
Search a comprehensive database of thousands of FDA Inquiries.
Includes correspondence, dates, and more.