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In Country Services
Synergy is focused on providing foreign pharmaceutical companies with the services they need to successfully enter the U.S. market...
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PreClinical / NonClinical
Design & management of preclinical programs. Preclinical Toxicology and Pharmacology consulting expertise and management. Pre-...
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Clinical Affairs
Pre-IND Program Evaluation and Development, Clinical Development Planning, Pre-IND meetings, IND services and filings, Phase I - I...
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Regulatory Affairs
Pre-IND / Pre-IDE regulatory services through NDA / PMA approval, the level of regulatory guidance Synergy Research provides stand...
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Medical Device Strategy-Architecture
Device development strategies, plan & implementation architecture. Creative solutions for 510(K), PMA, IDE, De Novo, Predicate...
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Animal Health Care Product Development
R&D programs for domestic animal health care products, farm and food animal programs, FDA/USDA regulated programs; INAD-NADA...
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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...
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Data Monitoring Committees / DSMB
Turnkey DMC / DSMB
Create an on-the-fly DMC, staffed by your selecting appropriate committee members from our extensive and exper...
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Pharmacovigilance: Pre & Post Launch
Single case processing, spontaneous reports, clinical and regulatory review, safety SOPs, special reports, MedDRA coding, WHOdd co...
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Pharmacoeconomics & Outcomes Research
Research programs designed for cost-benefit and economic issues relating to clinical use of drugs and devices, and therapeutic or...
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Licensing, JVs, Partnerships
Leveraging our in-house strengths in drug & device strategic development, we bring together partners in a tri-partite fashion
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Data Management Statistics Analysis
Data management, data entry, database programming, drug coding, MedDRA coding, CRF design, statistical design and analysis, data...
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Regulatory Guidances Around the World
FDA: Guidances, Code of Federal Regulations, MAPP, GLP, GMP, GCP, ICH.
ICH: Guidelines; Q; Quality Topics. S; Safety Topics. E;...
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Europe & Asia
Experience via our US staff, or working with our European and Asian partners / contract consultants, our reach extends globally....
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iPAD - iClinical
iPAD comes to clinical research here, with iCLINICAL for the iPAD. Amazing Savings in Time, Quality, Cost.
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Patient Registries
Patient Registries offer unique and creative solutions in a pre and post launch environment. Used for the collection of observati...
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Code of Federal Regulations [CFR]
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2009]
[CITE: 21CFR1]
TITLE 21-...
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Workshops & Lectures
Synergy Research conducts frequent seminars and workshops for the life science industry. Below please find our current calendar o...
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