Manufacturing problems leading to consent decrees…. Products being pulled from the market…. products that haven’t lived up to efficacy claims…. The patent cliff…. These sound like familiar challenges for the pharmaceutical industry. But as the generics industry has grown and matured, it is being met with greater scrutiny from regulatory agencies, forced to change its operating model to reduce costs, all while improving capabilities to bring new cheaper generics to markets. Manufacturing and quality issues along with lackluster demonstrative bioequivalence data that have raised questions about the sector’s safety and ultimate viability leading to plant shut down, products being barred/recalled, and millions of dollars in settlement with regulatory agencies and the need to submit substantiated bioequivalence data.
At Sciformix, we understand the importance of capital and cost optimization to you. Our delivery model and our services are designed to minimize upfront and operating costs while guaranteeing regulatory compliance. Our suite of services includes registration strategies and dossier compilation for specific markets, pharmacovigilance, aggregate reporting, labeling updates and a specially designed solution for literature case processing. We have developed an extensive knowledge base through our experience in supporting 500+ generic products across 140+ countries in activities such as medical call center, adverse event processing and authoring aggregate safety reports. We can set up a dedicated safety database for you or leverage your database investments.
We define our approach to suit your needs. From strategic planning and regulatory oversight to managing regulatory processes and preparing submissions to meet regulatory compliance requirements, our global experience helps pave your path to market success. Our flexible approach also allows you to pick and choose activities within our service portfolio. By offering an integrated drug delivery solution approach and leveraging our domain, process and technology expertise, we help our customers:
- Ensure that they meet the ever changing global regulatory landscape and achieve 100% compliance
- Balance resourcing as your portfolio adjusts to pipeline, regulatory and market fluctuations
- Lower risk and maximize value during product commercialization
- Reveal your product’s value to regulators, payers, providers and patients
Learn more about our Safety & Risk Management, Clinical Research & Post Approval Support Services and Regulatory Affairs expertise.