There are a variety of things that make life science Start-ups unique. For one, they are building a business from scratch, bringing a life-changing idea from concept through to actualization. An idea that is going to transform the lives of patients. The focus for Start-ups, in the early years is therefore (a) establishing the right management team, (b) securing funding (c) navigating their product through a complex research and development (R&D) environment to get that product approved in the market and into the hands of their patients.
It’s a lot of work for a business of any size to handle, let alone one that is just getting its feet under the table. That’s why many rely on a network of venders/contractors, particularly those that help them navigate the rigorous regulatory climate that is an essential part of drug approval. While there’s no shortage of companies providing regulatory/quality support for life science companies, there are very few that provide it exclusively to Start-ups. This is where DArcy Compliance Consulting (DArcy) excels.
DArcy has been supporting the needs of Start-ups for almost 10 years. They understand the unique needs of Start-ups including but not limited to:
- Start-ups are small entities and with no revenue stream from marketed products, resources are tight.
- They operate at breakneck speed and don’t have the luxury of large quality or compliance departments that can provide the right guidance on what Regulators expect to see.
- Decisions are made quickly and plans executed against a timeline that has no mercy.
So, in this context, it is especially important for Start-ups to work with a Partner that understands their needs and knows, from a Regulatory perspective, what is required and by when.
Regulators want to see evidence of quality in drug development and let’s face it, if demonstrable quality is not in place, then the path to approval becomes more fraught.
The Complex Product Life Cycle
Quality is key in drug development and Regulators want to see evidence of quality at all stages in clinical trials, from development of protocols right through to submission. Even the most incredible scientific breakthroughs will be never see patients if the Start-up does not meet the Regulator’s expectations around quality.
Medium/ large companies have a well established “machine” for moving new products from discovery, through preclinical, clinical, and manufacturing stages. They understand the need for quality and have the right systems in place to support quality across the organization. Start-ups do not have this luxury.
Start-ups are still establishing the basics. They don’t always have institutional knowledge nor resources to know what quality requirements are critical and when. How many SOPs should be in place? Who needs to be trained on what? That’s where DArcy Compliance Consulting comes in and excels at establishing ‘phase appropriate’ quality infrastructures.
We educate our Start-up clients on Quality requirements – specifically:
- ‘Phase Appropriate’ Quality – not everything is required at once.
- Foundational elements of Quality that should be established at the beginning of a study and built on, as a candidate progresses through Phase 2 and 3.
- Working with a CRO or vendor, means multiple SOPs are not required by the Start-up, just some key procedures as well as good oversight tools.
Importance of Quality Early in the Process
As with most important things in life, addressing quality as early as possible can save an organization a lot of time, money, and stress down the road. Too often a Start-up’s focus is on product and market development, which obviously are critical activities. However, no matter how good the product is, or how great the need, if quality requirements are not met, then they will fail at the first hurdle – FDA Approval. Quality needs to be a consideration as early as possible – even as early as protocol development.
The Dangers of Trying to Retrofit Quality
Failing to build quality early in development can cause unnecessary bumps down the road resulting in errors that ultimately lead to delays, repeat experiments/studies, wasted time, effort and ultimately cost. For a large organization, delays are inconvenient and costly but larger organizations can survive. For a Start-up, having to repeat a study can sink a program. Repeating a program can sink the organization. It is critical therefore to build Quality as soon as possible, and one of the best ways to do this is to partner with a organization who understands exactly what is needed and when.
Meet Your Compliance & Quality Experts
DArcy Compliance Consulting was formed to address a very specific need in the life science industry: the need for practical, implementable quality infrastructure for Start-ups. Whether you are looking for SOPs to be developed, training to be rolled out or, vendors to be audited, our team of experts are ready to assist. Contact us today to start the conversation.