SYNERGY Research

A mutually advantageous conjunction of distinct elements

DISCOVERY | RESEARCH | MONITOR | DATA SAFETY

Pharmacovigilance Solutions
  • 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)

  • Medical Review

  • Subject Narratives

  • Regulatory Support and Intelligence

  • Literature Search Services

  • EudraVigilance Reporting

  • Safety Medical Writing

  • Medical Information Support

Services
Services
Synergy Services
In 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, Phase
Regulatory Affairs
Pre-IND / Pre-IDE regulatory services through NDA / PMA approval, the level of regulatory guidance Synergy Research
Medical 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 Launch
Workshops & Lectures
Synergy Research conducts frequent seminars and workshops for the life science industry.  Below please find our current calendar
Data 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 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 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 fashion
Europe & 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.
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FDA Inquiries

Search a comprehensive database of thousands of FDA Inquiries.

Includes correspondence, dates, and more.

Need more details? Contact us

We are here to assist. Contact us by phone, email or via our social media channels.

Central 800-552-1680

© 2021 Synergy Research

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