Making sense of regulatory requirements
09th Jul 2021
The complex pharmaceutical regulatory landscape and the importance of a full-lifecycle partner.
The pharmaceutical sector is among the most highly regulated industries in the global economy. With so much to consider, maintaining regulatory compliance while accounting for regional nuances and phase-specific requirements can be quite challenging for pharmaceutical and biotechnology organisations. Successfully navigating the complex regulatory landscape requires an outsourced partner with a strong compliance track record, a dedicated team and expertise spanning every stage of the pharmaceutical lifecycle.
The global market for outsourced regulatory affairs in the pharmaceutical industry is expected to grow at a CAGR of 12.0% through to 2026.Comprehensive regulatory requirements throughout the full pharmaceutical lifecycle.
The complexity of regulatory compliance in the pharmaceutical industry is due, in part, to varied requirements and considerations at different stages of development and manufacture. It permeates the entire pharmaceutical lifecycle, and it is a key consideration for pharmaceutical and biotechnology organisations even in their projects’ earliest stages. Regulatory decisions at each stage have cascading implications down the line, so it is critical to work with a partner who views every phase in the context of the entire pharmaceutical lifecycle in order to mitigate added costs and delays in the long run. Deep analytical and regulatory expertise, as well as a robust understanding of the full project lifecycle, are fundamental for regulatory success.
How can an outsourced partner help enhance regulatory success at each stage?
In pharmaceutical development and manufacturing, each stage of the product lifecycle brings about its own key regulatory requirements and considerations. To best position themselves for regulatory approval, organisations require an outsourced partner that delivers support and expertise at each key stage—preclinical, clinical and commercial—and is committed to positioning each project for long-term compliance success.
In a project’s earliest stages, organisations are focused on quickly reaching clinical trials. Preclinical studies aim to establish sufficient data that a product is safe for humans , which must be detailed in the investigational application that is required before a product enters clinical trials. While speed to clinical trials is critical amid significant competition, organisations should take care to select a partner that helps them shape a CMC (Chemistry, Manufacturing and Controls) strategy that balances speed and costs while positioning the project for long-term success.
72% of pharmaceutical professionals cite regulatory compliance as a top factor when selecting a CDMO .
Success in clinical trials requires strong regulatory knowledge and robust analytical capabilities. From selecting an appropriate regulatory starting material to assessing impurities and defining a suitable cGMP strategy, organisations face a myriad of diverse considerations and complexities during the clinical stage. The precedents set in this stage can either streamline or hinder process improvement, making it critical to develop reference standards with the entire project lifecycle in mind. In addition, after a product progresses through clinical trials, a comprehensive new drug application (NDA) is required to commercialise the drug, affirming its safety, efficacy, and the quality of manufacturing processes.
Only 14% of drugs in clinical trials ultimately receive approval for commercial sale.
Regulatory agencies continue to closely monitor drug products after approval to ensure continued quality, safety and effectiveness. With the prevalence of drug recalls, organisations must take care to continue cGMP manufacturing practices and maintain stringent quality and safety standards. In addition, as an organisation refines and optimises manufacturing processes to realise new efficiencies, it is imperative to validate changes and deliver the necessary documentation to ensure continued compliance.
Around 85% of pharmaceutical recalls from the FDA result from quality issues.
True scientific partnership to maximise regulatory success.
At Sterling, we deliver the regulatory expertise and cGMP manufacturing capabilities required to ensure all of our customers’ products and processes are safe, quality-centred and compliant. We have been accredited by key regulatory agencies like the FDA and EMA, and our dedicated CMC team supports our customers through regulatory filings a teach stage of the pharmaceutical lifecycle. Most importantly, as a PDMO®, or partnership development and manufacturing organisation, we deliver the comprehensive support and close scientific collaboration needed to position our customers for regulatory success.
Service
We pride ourselves on being easy to do business with, removing layers of complexity, maximising flexibility and adaptability to your requirements, and doing what we say we will do, again and again.
Passion
We promise to treat your molecule as our own, drive progress by continually exploring new and emerging capabilities, and do the right thing for our people and planet.
Science
We combine our expertise in complex and hazardous chemistry, our world-class facilities, and our full-lifecycle capabilities to place scientific excellence at the core of every solution we deliver.
