Phase-Appropriate Development: #2

We need to comply with FDA requirements. How much is enough? If the basics are not in place, then development will not move forward. Studies will need to be repeated to generate the hard, documented data that is required for FDA.

Here are the 5 areas to focus on to make sure you are doing enough:

1. Documentation – Write Things Down:

“If it isn’t documented, it isn’t done.” Without a basic documentation system for capturing experimental results, manufacturing, and analytical testing, then there is no system of development. Many companies have trouble transitioning from a research environment to a commercial one. By having a phase-appropriate documentation system in place, companies can avoid costly errors and the need to repeat studies for submission to the FDA.

2. Quality Systems

Quality systems can be confusing and burdensome and are typically the last thing companies want to set up and abide by. This can result in many quality issues, lost batches, product delays, and project delay. Setting up an efficient system from the beginning can transform Quality to a multiplier of efficiency and way to make sure that the time and cost requirements are met.

3. IP Protection

Intellectual Property (IP) is constantly being generated at all phases of development. It is essential that staff are aware of this and are documenting and reviewing what they are doing with that in mind. IP is not just for lawyers – it will maximize the value of the company’s products and minimize delays or legal issues down the road.

4. Communicate with FDA and other Regulators

Many companies of all sizes are afraid to communicate with FDA and other regulatory authorities. Companies skip the opportunities for feedback because they are afraid of new requirements and admitting they haven’t done everything they need to yet. The result is that all communication comes at a high-pressure and high-risk moment, such as a response to Clinical Hold, when it could have happened in advance. You can get beyond this fear and communicate with FDA in a safe and effective manner to get the information you need to focus your development tasks.

5. Manufacturing Description and Training:

Too often, the product manufacturing is reliant on a small group of people or even in some cases a single person. This can lead to a dangerous overdependence on the same set of people and processes that are very hard to reproduce. Companies can establish documents and train alternates from the beginning to avoid delays, and allow those valuable people to develop new products or processes.

Harmony Consulting can make sure that you are doing the right amount of work and no more! If you find yourself facing any of these issues, give us a call and we can guide you forward to more efficient development.