The complexity and depth of challenges faced by the global pharmaceutical and biopharmaceutical industry has resulted in the need for these organizations to change their operating model to reduce costs, while improving their capabilities to enhance the drug development pipeline and bring new drugs to markets. Traditional operating models are being pushed to the point of breaking because of cost pressures, emerging competition, governmental and political demands and the weight of supporting global distribution channels. In response to these pressures, these industries are exploring new growth opportunities in emerging markets, strengthening their research and development by collaborating with industry and academic partners, and focusing on operational efficiency. Managing the complexity of drug development, approval and post-approval product maintenance processes, hiring specialists and resources and the ability to manage fluctuations in resource demands are key issues biopharmaceutical companies are facing.
While the issues large and mid-size pharmaceutical companies, as well as biopharmaceutical companies are common, there tend to be differences in the expertise sought in a service provider. The regulatory requirements for manufacturing and approval of biologics and biosimilars are different from traditional, small molecules. At Sciformix, our team of specialists understand these requirements and provide optimal solutions for all of our clients.
Our experience and understanding of the dynamic needs of an evolving portfolio of a mid-size pharma client, has enabled us to develop best practices in areas like maintenance of aggregate reporting schedule, as well as the use of standard templates and processes for reports, risk management strategies, adaptive study design and study quality surveillance.
Sciformix continues to invest in building expertise in both traditional drugs as well as biologics. Our delivery models and services complement our pharmaceutical (including mid and big pharma as well as biopharmaceutical) client’s needs. We specialize in knowledge-based processes and provide end-to-end services in a cost effective manner. Our flexible approach also allows you to pick and choose activities within our service offerings. Offering an integrated drug delivery solution approach by leveraging domain expertise, process and technology expertise, we help our customers:
- Integrate clinical, regulatory and commercial strategies to provide unique value
- Balance resourcing as the portfolio adjusts to pipeline, regulatory and market fluctuations
- Reveal product’s value to regulators, payers, providers and patients
- Make “go/no go” decisions through the entire product lifecycle
Learn more about our Safety and Risk Management, Clinical Research and Post Approval Support Services, and Regulatory Affairs expertise.