Elliot Brown Consulting and Ergomed CRO have launched PrimeVigilance, a new pharmacovigilance services company. Founded by two globally respected experts, the newly formed PrimeVigilance Ltd. provides a unique offering in the field of pharmacovigilance, more here...
Elliot Brown Consulting provides a dedicated pharmacovigilance resource for the international pharmaceutical and biologicals industries.
Our team of highly experienced pharmaceutical and regulatory affairs consultants and associates can provide expert and cost-effective solutions for:
Services include support for:
Our clients in 4 continents range from small generic and biotechnology companies to top-10 multinational pharmaceutical corporations. In addition Elliot Brown Consulting is proud to be associated with PrimeVigilance a dedicated pharmacovigilance outsourcing service provider, enabling you to fully outsource your entire pharmacovigilance operation while keeping tight control of costs, quality assurance and regulatory compliance.
Our consultants are at the leading edge of developments in pharmacovigilance and therapeutic risk management. Elliot Brown Consulting offers a range of services including:
Elliot Brown Consulting provides audits of pharmacovigilance compliance with a unique feature. Dr Stephen Goldman, formerly a senior FDA official and Dr Elliot Brown, a former senior UK and EU regulator, bring both US and European top-level regulatory perspectives to this activity.
Together with our team of pharmacovigilance and pharmacoepidemiology experts, we can provide cost-effective tailor-made assessments. Audits may range from examination of SOPs and working practice documents to site visits world-wide, including system and process reviews and practice regulatory inspections.
Risk assessments, corrective action plans, process mapping, change management, system validation, drawing up third party contracts, writing SOPs, performing due diligence: our expert team of consultants can help whatever your company’s needs.
Elliot Brown Consulting has significant expertise in all aspects of PSURs with extensive experience of writing PSURs, training staff from companies and regulatory agencies and reviewing and advising on PSUR strategy for major multinational corporations.
Services on offer include:
Elliot Brown Consulting brings expertise and experience without equal to the implementation and management of MedDRA and other dictionaries as well as in the selection and installation of safety systems and processes. Available services include:
Useful sites
| PrimeVigilance: Pharmacovigilance outsourcing and service provider | http://www.primevigilance.com |
| Inpharm | http://www.inpharm.com |
| ABPI | http://www.abpi.org.uk |
| DIA | http://www.diahome.org |
| WHO | http://www.who.ch |
| EU Commission | http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm |
| ISPE | http://www.pharmacoepi.org |
| MedDRA | http://www.meddramsso.com |
| CSM (now CMH) | Commission on Human Medicines |
| GPRD | General Practice Research Database |
| NICE | National Institute for Clinical Excellence |
| Medicines compendium | Medicines.org.uk |
| Pharmacovigilance Information | Pharmacovigilance Information |
Regulatory authorities:
http://www.fda.gov
The European Medicines Agency
Austria / Federal Ministry of Labour, Health and Social Affairs
Belgium / The Directorate-General Public Health Protection
Denmark / Danish Medicines Agency
Finland / National Agency for Medicines
France / Agence Francaise de Securite Sanitaire des Produits de Sante
Germany / Federal Institute for Drugs and Medical Devices (BfArM)
Greece / National Drug Organization
Iceland / Icelandic Medicines Control Agency (MCA)
Ireland / Irish Medicines Board
Italy / Ministry of Health
Luxemburg / Division de la Farmacie et des Médicamentes
Netherlands / Medicines Evaluation Board
Norway / Norwegian Medicines Agency
Portugal / INFARMED / The National Pharmacy and Medicines Institute
Spain / Agencia Española de Medicamentos y Productos Sanitarios
Sweden / Medical Products Agency
Australia / Therapeutic Goods Administration (TGA)
Japan/ National Institute of Health Sciences, Japan
Canada / Therapeutic Products Directorate
USA / The Food and Drug Administration (FDA)
UK / MHRA
Heads of agencies
Elliot Brown Consulting Ltd
Registered Office:
Russell House,
140 High Street,
Edgware,
Middlesex HA8 7LW
Registered in
England and Wales.
Reg No. 3691390