Founder, Executive Business Partner at Paularc Consulting Inc. - Guelph, Ontario, Canada
Paularc Consulting Inc. is a specialized regulatory consulting firm dedicated to meeting the individual needs of its clients in the Canadian agricultural industry that includes the crop protection business by providing comprehensive:• Efficacy and Crop Tolerance Summaries (DACO 10)• Residue Summaries (DACO 7)• Scientific reports, rationales/data waivers• Literature and critical peer-review support• Data mining, processing, and management efforts• Statistical (meta-) data analyses (uni- and multi-variate, parametric and non-parametric)• Study/trial placement and management with external CRO's• Dossier management (e.g., Cat. A to F, label development) and electronic submission to PMRA• Communication with PMRA and client on submission review status and requests• Pre-submission consultations with PMRA• Post-market PMRA review support (e.g., data call-ins for re-evals and special reviews)• PMRA annual charge/sales and incident reporting and filing• Representation as a Canadian agentQuality and consistency of delivery on projects within scope, time, and budget is paramount at Paularc. This is driven by a highly professional and collaborative work ethic and spirit that fosters personal and professional development while building long-term professional partnerships based on mutual trust, reliability, and understanding.