Marketing Authorization Application (MAA)

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

Our medical writing agency will prepare your Common Technical Document (CTD) or sections of your CTD for you, in accordance with ICH standards. Depending on your needs, our medical writers can write all or part of the clinical (module 2.5, clinical overview and module 2.7, clinical written and tabulated summaries) and nonclinical modules (module 2.4, nonclinical overview and module 2.6, nonclinical written and tabulated summaries). We have extensive expertise in preparing the pharmacokinetic and pharmacodynamic (2.5.2 and 2.7.2), clinical efficacy (2.5.3 and 2.7.3), and clinical safety sections (2.5.4 and 2.7.4), as well as the nonclinical modules (2.4.3 and 2.4.4, and 2.6.4, 2.6.5 and 2.6.6). As part of our service, we can perform a critical appraisal of the medical literature for you in order to select and rank published data prior to their inclusion in the 2.4, 2.5, 2.6, and 2.7 modules. Find more details on our state-of-the-art review writing services in the “Literature reviews, state-of-the-art reviews” section.

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.