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News & Events

  • GSK Receives EMEA Approval for Duodart LONDON (AP) - Pharmaceutical company GlaxoSmithKline... Read more>>
  • in vivo Pharmacodynamic Assay Trevigen offers a validated assay with higher sensitivity and... Read more>>
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  • U.S. Food & Drug Administration (FDA) New and Generic Drug Approvals Calan (verapamil h... Read more>>
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  • FDA Requests More Information on Certriad LONDON (AP) - AstraZeneca PLC and Abbott Laborator... Read more>>
  • FDA Approves Mylan’s Drug Applications Mylan Inc. Monday announced that its subsidiary Mylan Ph... Read more>>
  • FDA Says Additional Pixuvri Trial Needed, CTI Opens Drug to Expanded Access Cell Therapeutics... Read more>>
  • Mapping Technique Speeds Finding Specific Genes A Purdue University scientist was part of a... Read more>>
  • Novozymes Partnering With ProMetic Life Sciences Inc.Drug Discovery & Development - April 0... Read more>>
  • Proximagen Signs Deal With Upsher-Smith Proximagen Neuroscience plc, a biotechnology company... Read more>>
  • New Class of Brain-Protecting Drugs Emerging Researchers have identified a compound that mim... Read more>>
  • In Country Services

    Synergy is focused on providing foreign pharmaceutical companies with the services they need to successfully enter the U.S. market... Learn more>> In Country Services
  • PreClinical / NonClinical

    Design & management of preclinical programs. Preclinical Toxicology and Pharmacology consulting expertise and management. Pre-... Learn more>> PreClinical / NonClinical
  • Clinical Affairs

    Pre-IND Program Evaluation and Development, Clinical Development Planning, Pre-IND meetings, IND services and filings, Phase I - I... Learn more>> Clinical Affairs
  • Regulatory Affairs

    Pre-IND / Pre-IDE regulatory services through NDA / PMA approval, the level of regulatory guidance Synergy Research provides stand... Learn more>> Regulatory Affairs
  • Medical Device Strategy-Architecture

    Device development strategies, plan & implementation architecture. Creative solutions for 510(K), PMA, IDE, De Novo, Predicate... Learn more>> Medical Device Strategy-Architecture
  • 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... Learn more>> Animal Health Care Product Development
  • 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... Learn more>> Rx-to-OTC Switch Programs
  • 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... Learn more>> Data Monitoring Committees / DSMB
  • Pharmacovigilance: Pre & Post Launch

    Single case processing, spontaneous reports, clinical and regulatory review, safety SOPs, special reports, MedDRA coding, WHOdd co... Learn more>> Pharmacovigilance:  Pre & Post Launch
  • Pharmacoeconomics & Outcomes Research

    Research programs designed for cost-benefit and economic issues relating to clinical use of drugs and devices, and therapeutic or... Learn more>> Pharmacoeconomics & Outcomes Research
  • Licensing, JVs, Partnerships

    Leveraging our in-house strengths in drug & device strategic development, we bring together partners in a tri-partite fashion Learn more>> Licensing, JVs, Partnerships
  • Data Management Statistics Analysis

    Data management, data entry, database programming, drug coding, MedDRA coding, CRF design, statistical design and analysis, data... Learn more>> Data Management Statistics Analysis
  • 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;... Learn more>> Regulatory Guidances Around the World
  • Europe & Asia

    Experience via our US staff, or working with our European and Asian partners / contract consultants, our reach extends globally.... Learn more>> Europe & Asia
  • iPAD - iClinical

    iPAD comes to clinical research here, with iCLINICAL for the iPAD.  Amazing Savings in Time, Quality, Cost. Learn more>> iPAD - iClinical
  • Patient Registries

    Patient Registries offer unique and creative solutions in a pre and post launch environment.  Used for the collection of observati... Learn more>> Patient Registries
  • Code of Federal Regulations [CFR]

    [Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2009] [CITE: 21CFR1] TITLE 21-... Learn more>> Code of Federal Regulations [CFR]
  • Workshops & Lectures

    Synergy Research conducts frequent seminars and workshops for the life science industry.  Below please find our current calendar o... Learn more>> Workshops & Lectures