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
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
Health News - Africa
- Uganda: Covid-19 Stands in the Way of HIV/Aids Fight
- Seychelles: Health Official Warns of Possible Rise in HIV/Aids Cases in Seychelles During Year of Covid
- Malawi: Malawi Prisons Registers No Covid-19
- Malawi: Malawi Makes Progress in HIV and Aids Fight - Chakwera
- South Africa: Aids Victories Show What We Can Do If We Try
- Ethiopia: HIV/ Aids in Alarming Rate in Addis Ababa - Office
- Africa: South Africa Has the Best HIV Policies, Report Finds
- Africa: A critical HIV situation in Central African Republic - A state of silent crisis
- South Africa: Will Covid-19 Vaccines Bring Life Back to Normal in 2021?
- South Africa: Western Cape Finance and Economic Opportunities Releases Procurement Disclosure Report On Covid-19 Spending