Syncorp provides regulatory services to facilitates all types of drug/device development and provides interdisciplinary strategy plan to obtain the most effective and efficient regulatory pathway.
We compile, organize, write and edit safety documents that include study Protocols, Investigator Brochure, Informed Consent documents, Clinical Study Reports, Common Technical Documents and Aggregated Reports (PSURs, NDA) which are followed in clinical trial services.
In depth knowledge, we provide expert advice for clinical development in specific areas such as: -
-> Clinical trial regulatory support includes submission requirements, preparation and management of clinical trial applications to regulatory authorities, substantial amendments and end of trial and study outcome reporting.
-> Regulatory Consultancy includes study design, clinical development, preparation for regulatory authority meetings, advanced therapy medicinal products.
Our end to end solutions to provide take you from strategy, audit, submission, publishing and post- licensing support with the support of our team members.
Syncorp can provide clinical trial activation and maintenance, regulatory consulting and strategy planning and formal regulatory meetings with regulatory affairs as per the authorities.