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Medical Writing

Regardless of your medical product study phase, our highly skilled medical writers can save you time and money by clearly and accurately writing the medical documents your development program requires. Our commitment to strong medical communication will provide you with thoughtful, cohesive medical documents that will stand up to regulatory and industry scrutiny. Below are examples of the various medical documents we routinely write:

Investigational Medical Product Applications
Investigational new drug (IND) submissions
Investigator’s brochures
Literature reviews and summaries
Standard operating procedures (SOPs)

New Drug Applications (NDAs)/Registration
Summary of clinical safety/ISS
Integrated summary of efficacy (ISE) reports
Clinical pharmacology
Non-clinical pharmacology and
toxicology
Benefit-risk analyses
120-day safety records
Clinical Development Phases I-III
Informed consents
Protocols
Annual safety reports
Clinical study reports
Regulatory reports
Serious adverse event (SAE) narratives

Post-Marketing
Periodic safety update reports (PSURs)
Periodic adverse drug experience reports (PADERs)
Manuscripts
SAE narratives
Regulatory reports

 


 
CONTACT US

 
Timothy Cartwright, BS
Director, Pharmacovigilance Systems
Maria Vazquez-Gragg, MD, MPM
Global Head, Safety and Pharmacovigilance

US: +1.800.262.3011
Spain: +34.93.241.7766
UK: +44(0)161.232.3400
For a full list of scientific staff bios, click here.

 
  Other

FDA's Guidance for Industry:
Directive 2001/20/EC (Clinical Trial Directive of 4 April 2001)

EMEA's Guidance
Pharmacovigilance for Medicinal Products for Human Use

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