Pharmaceutical Resource, Corp.

Description

We cover the regulatory aspects of every stage of your product's lifecycle including pharmaceutical (CMC/quality) consulting, non-clinical (pharmacology/toxicology) consulting, clinical pharmacology consulting, and therapeutic/biostatistical consulting, as well as pre-approval and post-approval regulatory operational support. Doing so, we provide timely input into your development activities to carry your products efficiently right the way through their lifecycle.

We provide secure management of your regulatory documents (via Share Point), and we provide both paper and electronic publishing in CTD format (using Insight Publisher v5.0).

We often find sponsors’ existing Quality Management Systems are restrictive and unnecessarily complex, placing an ever-increasing training burden on end-users. Using our global Quality & Compliance experience, we can help you streamline your quality processes to drive cost and time efficiencies. Simplifying your processes will also lead to better compliance. We will assess the validity of your existing SOPs, suggesting improvements and/or developing new ones. We can also help you select the best-quality vendors for your particular projects and review your vendor oversight processes.

Extrapolating the value of a CRO’s historical experience database to your trial’s needs today can be tricky. Our CNS leadership team uses its extensive view of industry successes and failures, in combination with INC Research’s formidable knowledge base, to select the most relevant implementation strategies, experienced teams, and best practices. We are guided by this focus on relevant experience and expertise combined with our acclaimed continuous improvement engine (the Trusted Process).

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