5 tips
1.      Make sure a Change Control (CC) case is opened and that a project is set up, together with relevant co-workers. This is important, also for smaller changes.

2.      Correct classification is key. Study the classification guideline carefully and ask a colleague for advice if you feel unsure. For non-standard variations, always confirm the classification with the agency.

3.      Go through your dossier, what documentation is affected by the change? Also consider documents outside module 3, such as the product information.

4.      Compile the variation package as required for your variation type and ask a colleague to review it with ”fresh” eyes before submitting to the agency.

5.      Be clear about agency timelines, when communicating with the manufacturer. This will facilitate well-planned and correct implementation of the change.

Seem complicated? Contact us. At RegFile we have extensive experience in CMC variations and extensions, both from industry and competent authorities.

*Regulatory changes concerning Chemistry, Manufacturing and Control