Building an EU regulatory strategy (3)

4. Ensure comparability

Sometimes small companies don't have the resources or the analytical technology they need in the early stages, so they must evaluate their analytical process early on. If any changes are made, the regulators will want you to show that the product from the early processes and the later processes are comparable. Changing your process may render your previous product irrelevant to the new compound if comparability cannot be proven, explains Kirke. "Changes often come in having to scale the process up and it's in those stages where you have to be very careful in building a consistent process," he adds.

But this isn't necessarily a problem if it's expected and planned out. Companies will do better to have the needed analytical technology, but for those that cannot afford it, Kirke recommends keeping samples from every stage. At a later date when you can afford or have access to the necessary analytical technology, you can go back and compare the samples. There is an added risk here: if the samples are not comparable, companies will not find out until it's too late.

It's critical that changes are accounted for before beginning the clinical program. "If you find differences in chemical characterization, then it may be necessary to do more non-clinical, or even clinical, work," explains Kirke. "If they're different, you may need to complete your entire clinical program. It's better to work this out in the first place so you don't have to make these changes."

5. Stay informed of regulatory requirements.

In addition to attending regulatory meetings, companies should make sure to review the agencies' websites on a regular basis to stay abreast of any changes in regulations or new guidelines relevant to your product. You want to know about these things as soon as possible. "We see a lot of companies that don't keep up to date with the current regulatory requirements," says Cronin. "Keeping up to date with that and using various tools to do that is essential to ensure that you don't have to go back and repeat things."

Want more expert advice? Then check out this archive of previous FierceBiotech advice columns.

Building an EU regulatory strategy (3)
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