SYNERGY Research

A mutually advantageous conjunction of distinct elements
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DISCOVERY | RESEARCH | MONITOR | DATA SAFETY

Pharmacovigilance Solutions
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  • 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

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Services
Services
Services

Synergy Services

In Country 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
PreClinical - NonClinical

Design & management of preclinical programs. Preclinical Toxicology and Pharmacology consulting expertise and management. Pre-...

Clinical Affairs
Clinical Affairs

Pre-IND Program Evaluation and Development, Clinical Development Planning, Pre-IND meetings, IND services and filings, Phase

Regulatory Affairs
Regulatory Affairs

Pre-IND / Pre-IDE regulatory services through NDA / PMA approval, the level of regulatory guidance Synergy Research

Medical Device Strategy/Architecture
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.
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...

Rx-to-OTC Switch Programs
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

Pharmacovigilance: Pre & Post Launch

Workshops & Lectures
Workshops & Lectures

Synergy Research conducts frequent seminars and workshops for the life science industry.  Below please find our current calendar

Data Monitoring Committees
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

Patient Registries offer unique and creative solutions in a pre and post launch environment.  Used for the collection of observati...

Pharmacoeconomics/Outcomes Research
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
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
Licensing, JVs, Partnerships

Leveraging our in-house strengths in drug & device strategic development, we bring together partners in a tri-partite fashion

Europe & Asia
Europe & Asia

Experience via our US staff, or working with our European and Asian partners / contract consultants, our reach extends globally....

IPAD Clinical
IPAD Clinical

iPAD comes to clinical research here, with iCLINICAL for the iPAD.  Amazing Savings in Time, Quality, Cost.

FDA Inquiries

Search a comprehensive database of thousands of FDA Inquiries.

Includes correspondence, dates, and more.

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