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documentation and regulatory
Documentation in early drug development links early research data, preclinical designs and future clinical studies. In communication with investors, collaborators and investigators, and for building the regulatory package, documentation at the right level is crucial.
Clinical trials are an important part of the development of new drugs to ensure safety and efficacy. Drug development, clinical trials and market authorisation processes are governed by legislation controlled by national and global authorities and include scientific and ethical review. Currently the regulatory framework is facing many changes all over the world. The collected experience from drug development at Truly Labs spans from early pre-clinic to clinical, includes systemic (oral, intravenous) as well as topical (inhalation or dermal) products, and we have long experience of both small molecules and antibodies in many therapy areas. This unique blend of knowledge ensures a deep understanding in the interpretation of pre-clinical and early clinical data.
We identify the regulatory pathway and build the regulatory package (eCTD) from start with your data in focus. We help to document at the right level from “Good Scientific Practice” to Good Laboratory Practice (GLP) and define your needs for a personalized medicine strategy and biomarker assay development/analyses.
We provide you with strategic advice and key planning documents:
