Regulatory Affairs

The Context

The preparation of clinical trial applications to and liaison with Ethics Committees (EC), Competent Authorities (CA) and Ministries of Health (MoH) are specialised regulatory tasks. For large multi-centre studies efficient completion of this step can make all the difference between meeting the projected timelines and being left behind.
At Pharmalys we have experienced staff dedicated to managing the ethics and regulatory approval processes.
Our in-depth knowledge of local and international regulatory requirements guarantees that regulatory approval processes are expertly managed by associates who have many years of experience in this area.

Our services include:
- Preparation of the submission dossier for ECs and CAs/MoHs
- Attendance at EC meetings together with the sponsor and/or Chief Investigator
- Liaison with CAs/MoHs
- Support given to investigational sites/research institutions for their local submissions
- Communication of approvals in a timely manner
- Periodic reporting required by ECs and CAs/MoHs on study status and safety information

Pharmalys also provides regulatory support for applications for market authorisation of new drugs or new indications

Our Solutions

Early Stage Clinical Trials / Phase II and III Clinical Trials
Late Phase Clinical Trials / Post Marketing Safety Studies
Product Value and Effectiveness in Real-world
Public Health and Social Science Research