Our medical writing services include the writing of regulatory submissions such as Investigational Medicinal Product Dossiers (IMPDs), Investigational New Drug Applications (INDs), Marketing Authorisation Applications (MAAs), New Drug Applications (NDA) and Common Technical Documents in paper (CTD) and electronical form (eCTD). We also write investigators brochures, trial protocols, patient narratives and study reports. All documents that we provide comply with ICH guidance and regulatory requirements. |