Despite strong favorable signs from highly engaged regulators, accelerated regulatory pathways and special designations for cell and gene therapies, only a few have been approved so far. For the ones that were approved, the number of patients enrolled in pivotal studies were significantly lower than for traditional drug approvals.
Making the best out of these opportunities and achieving a successful fast-track approval requires specialized and dedicated regulatory knowledge and experience, specific to the emerging field of cell and gene therapy.
Regulatory milestones during the traditional drug lifecycle
The traditional drug development lifecycle is the same for cell and gene therapy programs, but is often very compressed, creating both opportunities for a faster pathway to commercialization, as well as challenges to meet key milestones and avoid bottlenecks towards cGMP readiness.
Regulatory needs in the cell and gene therapy space
Our regulatory cell and gene therapy offering is customized to support you at each critical time and milestone as your therapy progresses through the regulatory pathway towards its commercialization.
Our approach to de-risk your regulatory pathway, with continuous support throughout the product lifecycle
The regulatory services we provide serve one main purpose: to de-risk your regulatory pathway. In the pioneering field of cell and gene therapy, companies are trailblazing and achieving many 'firsts' in the field. They need the ability to rely on a dedicated partner that will provide the expertise and experience they need to focus on the science and the efficacy of their drug. So how can we de-risk your therapy's pathway?
In the evolving field of cell and gene therapy, best-in-class regulatory support starts with monitoring and staying fully up-to-date with the latest regulatory trends and landscape. We do this through our active involvement in regulatory conversations in industry, through our alliances and partnerships during dedicated regulatory workshops. We are proud sponsors of the Alliance for Regenerative Medicine (ARM) and its legislative fly-in meeting, which we join each year and leverage our practical experience to advocate for favorable regulation in the field of cell and gene therapy.
We'll partner with you to identify the appropriate number of runs prior to IND/IMPD filings and PPQ to support the success of your filings. We will also work to anticipate and be prepared for facility and equipment questions and audits.
As you progress through the regulatory pathway, your regulatory needs evolve. As a true partner, we will support you each step of the way, with the right, scaled service you need.
|cGMP support||Strategic and technical support||Regulatory submission support|
Our raw/starting materials specifications include:
- Qualification Program
- Single source
- Research Use Only
- Additional testing (e.g. FBS)