All key milestones in the drug development process require its specific documentations. The Drug Development Team is highly experienced in the writing of the regulatory documentations needed in all stages of development. We will ensure clear written and high quality communications for regulatory agencies, sites, investigators throughout the product development and commercial processes.
We can prepare the nonclinical sections of your regulatory documents, such as Investigators brochures, eCTD for IND, IDE, NDA, BLA, ANDA, MAA, PMA, DMF and other drug submissions throughout the globe, including the preparation of briefing packages and response documents. Also, we can assist you in the writing of an Orphan Drug application and Pediatric Investigation Plan. In addition, we can write the nonclinical sections of clinical safety and pharmacovigilance documents such as Annual Safety reports, PSUR and Risk Management Plans. Other documentations include expert reports, white papers, literature reviews and abstracts.