Our Expertise

Regulatory Affairs and Operations

Ensuring a safe and quality product while maintaining regulatory compliance

Significant increases in fixed costs of in-house resources for regulatory affairs and operations activities, such as facilities, technology, training, specialized knowledge and geographic regulatory expertise are driving life science organizations to a blended variable cost approach – one that optimizes outsourcing costs versus full-time staffing costs for a defined set of functions, programs and products. The benefits life science companies can realize from outsourcing regulatory affairs include significant cost efficiencies and refocusing staff time on core competency and other more strategic activities.

Sciformix’s end-to-end global regulatory affairs and operations services support regulatory strategy for product development trials and operational processes, and our expert staff will ensure your products compliance. Our specialists will help you keep your products on the market and expand your market share by implementing proactive compliance, gaining revenue in new markets, increasing speed to new market approvals, and extending brand formulations and indications. We also offer strategic, technical and operational guidance throughout the entire product lifecycle, from filing of marketing approvals of new products or maintenance of products in regulated and emerging markets to preparation for regulatory agency meetings and submissions.

We provide Global Regulatory Affairs Outsourcing and Operations expertise to support your pre- and post-launch activities in: