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, we 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.

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.