Our regulatory experts ensure compliance with all current and near future FDA regulations and field guidances, minimizing the risk of FDA review delays.
IMPECCABLE LABORATORY DATA
Placing an extremely high value on data integrity, reliability and reporting methods ensures any required data is compiled in a way that maximizes the understanding of the regulatory review of the requested changes.
The costs of time and materials to demonstrate the safety and efficacy of a change can seem daunting, especially coupled with the potentially tenuous review and approval cycles with regulatory bodies. Risk aversion often leaves owners in a less than desirable relationship where they are unable to realize the maximum margins available to the world market.
Successful applications often outgrow the initial forecast and manufacturing plan to meet growing market demand. By partnering with ideal manufacturers, together we tackle the growing drug shortages plaguing our most vulnerable customers who need us the most.
SUPPLY CHAIN RISK REDUCTION
Recent world events have taught us the potential fragility of the previous supply chain environment. We intimately understand the impact of unforeseen disruptions and we offer a variety of solutions including second source approval and identifying trusted partners that will be able to meet expected demand on a consistent basis.
The complete approval of required or desired changes on the initial request can be the difference between entering thriving market conditions or missing the boat. Understanding the expectations of regulatory compliance and industry leaders gives us and our partners the highest probability of a successful outcome the first time.
MARKET ACCESS AND IMPACT
We offer unparalleled inside market knowledge to help strategically position our partners for short- and long-term market capitalization and trending.
Our web of auditing experts around the globe offer a comprehensive evaluation and risk mitigation of key suppliers throughout the selection and qualification process.