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Marketing Authorization Application (MAA)

Common Technical Documents (CTDs) to ICH standards: Clinical and Nonclinical

120-Day Safety Update or 4-Month Safety Update (4MSU)

After submitting a Common Technical Document (CTD) to the Food and Drug Administration (FDA) for a New Drug Application (NDA), an updated report on product safety must be provided to the FDA within 120 days of the original submission. This report, also known as the 4-Month Safety Update (4MSU), contains any new information about the safety of the drug that could reasonably affect the contraindications, warnings, precautions for use or adverse reactions indicated in the proposed product information leaflet and label. Our experienced team can assist you in the drafting of this type of document.

Drug Abuse Liability Assessment (DALA)

For certain products that have abuse potential (e.g., psychoactive substances), the Food and Drug Administration (FDA) requests a specific Drug Abuse Liability Assessment (DALA) report at the time of submission of the Common Technical Document (CTD). If your drug product falls within this framework, our medical writing team can help you write this document according to the FDA recommendations.

Pediatric Investigation Plans (PIPs)

The Pediatric Investigation Plan (PIP) is an essential document, required before initiating any marketing authorization application (MAA), variation or extension to an existing marketing authorization (MA) and clinical trial. Our team has the expertise needed to write your PIP, optimizing your chances of approval by the competent authorities.

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