Medical Writing Services

"Expert support for your staff that you can turn on and off as required!"

Pharmacovigilance Reports

Periodic Safety Update Reports (PSURs)
Development Safety Update Reports (DSURs)
PSUR Addendums & Summary Bridging Reports
Risk Management Plans
Safety Reviews & Summaries
SAE Narratives
Risk Benefit Assessments
'Response to Questions' Documents

Clinical/Regulatory Reports

Clinical study reports for phase I-IV trials to ICH guidelines
Investigator's brochures
Study protocols & protocol amendments
Regulatory submission documents (CTD modules)
'Response to Questions' Documents

Publications/Congresses

Manuscripts for publication in peer-reviewed journals
Literature reviews
Congress abstracts and poster presentations
Conference/scientific meeting reports
Advisory board meeting reports

How we do it

In accordance with regulatory guidelines
In adherence to your company's SOPs & timelines
On site/off site, according to your needs

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