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

Why Africa

Africa offers an increasing number of experienced researchers through networks of excellence implemented ...

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At Pharmalys we believe in the value of partnership, sharing knowledge and establishing synergies in order to develop innovative solutions ...

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Become an Investigator

You can make a difference to a noble cause by getting involved in health related studies

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Pharmalys Ltd UK
Tel: +44 208 0909 620

Pharmalys SARL Senegal
Tel: +221 33 825 42 43

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