Paularc Consulting Inc

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 preparation, 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 agent Quality 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.