Worldwide Clinical Trial Applications (CTA) and Marketing Authorization Applications (North and South America, EU, Asia-Pacific, and Emerging Markets)

Pharmatech offers best-in-class regulatory expertise to ensure that your submissions and agency negotiations proceed as smoothly and effectively as possible. We have experience in each therapeutic area with marketing authorization applications across the globe. In addition to authoring CTD sections, our staff is also experienced at crafting responses to information requests (IRs) from health authorities to address their clinical, CMC, and non-clinical concerns. For markets that require electronic submissions, Pharmatech can prepare and submit your documents in electronic format (eCTD).