Ensure Regulatory Compliance

We stay current with industry best practices and mandatory regulatory reporting requirements. Our focus allows us to provide solutions tailored to individual client needs.

We deliver flexible, client-driven solutions to mitigate risk and ensure regulatory compliance. Pharm-Olam offers integrated services for multi-national studies to help sponsors develop and implement safety and surveillance programs for products across all therapeutic areas. Our safety data base, developed by ARISg, is a validated 21 CRF Part 11 compliant for all phases of clinical trials and post-marketing pharmacovigilance.

Pharmacovigilance Experts

Our pharmacovigilance experts specialize in managing clinical trial AEs and SAEs, including initial receipt, case processing and follow-up, medical review, and closure. Our services include:

AE case processing including SAE management and expedited reporting in the US, EU, and other countries
Responsible Person for EudraVigilance
Generation of MedWatch 3500A/CIOMS I forms
Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction

Pharmacovigilance Brochure

Download our Pharmacovigilance Brochure to see all services.

Argentina (Buenos Aires), Belarus (Minsk), Belgium (Brussels), Brazil (São Paulo), Bulgaria (Sofia), Canada (Toronto), Croatia (Zagreb), Czech Rep. (Prague), Georgia (Tbilisi), Germany (Munich), Hungary (Budapest), India (Bangalore), Italy (Milan), Kazakhstan (Almaty), Mexico (Mexico City), Poland (Warsaw), Romania (Bucharest), Russia (Moscow, St. Petersburg, Novosibirsk), Serbia (Belgrade), Spain (Madrid), South Africa (Johannesburg), Ukraine (Kiev), United Kingdom (London), United States (Houston, Princeton, Research Triangle Park)