Elliot Brown Consulting Ltd - Pharmacovigilance Services

Pharmacovigilance Services

Elliot Brown Consulting - Pharmacovigilance Services

The monitoring of clinical trial safety and the continuing surveillance of marketed medicines are vital responsibilities for pharmaceutical companies. However, the regulatory requirements have become increasingly complex in recent years and specialist knowledge is needed to fulfil the stringent obligations. In addition, the occurrence of a new safety concern with a medicine can have the most serious consequences and needs effective and timely management.

Services on offer from Elliot Brown Consulting include:

Risk Management Plans
Pharmacovigilance Plans
Routine safety surveillance and signal review
Safety strategy, procedures and systems
Review of new safety issues
Preparation or review of periodic safety update reports
Advice on investigation of safety signals
Representation to regulatory authorities
Review of benefit-risk
Crisis management
Review of safety studies / post-authorisation surveillance studies (SAMM / PASS)
Audit of company, department or site practices and procedures
Training on pharmacovigilance
Assistance with Third party agreements / contracts
Assistance with database implementation
Advice on safety surveillance for devices
Organisational review and change management

Elliot Brown has collaborative relationships with consultants in the United States, to provide a global perspective and to facilitate cost-effective work on both sides of the Atlantic.

Elliot Brown Consulting Ltd
Registered Office:
Russell House,
140 High Street,
Edgware,
Middlesex HA8 7LW
Registered in
England and Wales.
Reg No. 3691390