Synergy Services

Synergy is focused on providing foreign pharmaceutical companies with the services they need to successfully enter the U.S. market...

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

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

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

Device development strategies, plan & implementation architecture. Creative solutions for 510(K), PMA, IDE, De Novo, Predicate...

R&D programs for domestic animal health care products, farm and food animal programs, FDA/USDA regulated programs; INAD-NADA...

Data management, data entry, database programming, drug coding, MedDRA coding, CRF design, statistical design and analysis,

Rx-to-OTC switches: full switch (NDA supplement), partial switch (new NDA); OTC NDA, OTC Drug Monograph, Label Comprehension Studi...

Pharmacovigilance: Pre & Post Launch

Turnkey DMC / DSMB Create an on-the-fly DMC, staffed by your selecting appropriate committee members from our extensive and exper...

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

Outcomes Research Research programs designed for cost-benefit and economic issues relating to clinical use of drugs and devices, and therapeutic or...

DA: Guidances, Code of Federal Regulations, MAPP, GLP, GMP, GCP, ICH. ICH: Guidelines; Q; Quality Topics.  S; Safety Topics. E;...

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

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