International and Local Expertise in regulatory compliance is the starting point of AbCRO's quality services. AbCRO is experienced in the regulatory requirements and environment of each of the countries in which it operates. By having knowledge of local customs and connections to drug regulatory agencies, AbCRO is able to streamline the regulatory process for clinical trial approvals in the shortest time possible, which translates to faster patient enrollment for our clients.

AbCRO's regulatory activities include certified translations, regulatory package assembly and submission, cGCP training and audits, and SOP development and review.

AbCRO has a centralized regulatory filing procedure and all regulatory documents are filed at AbCRO's offices under strict confidentiality. All regulatory documents are maintained, updated, audited and archived according to cGCP and ICH guidelines. Additionally, AbCRO has standard operating procedures (SOPs) in place for all aspects of clinical trial conduct which are reviewed and updated on a regular basis.