In a recent encounter, I engaged with a client navigating an urgent regulatory challenge—an API supplier’s GMP certificate had been revoked. The catch? They were the sole source of a critical product, necessitating a rapid change.
This product serves 7 EU member states, and its license falls under the DCP procedure.
Here’s the essence of my response to their urgency:
Clarity is Key: Regulatory requirements can be complex, often lost in translation among stakeholders. For instance, we needed a QP Declaration as part of the variation package. We ensured everyone understood its implications on vendor assurance, supply chain, and quality. Clear communication became our cornerstone.
Effective Communication: To ensure no details were lost in the shuffle, we went beyond emails. Meetings and discussions were pivotal in conveying the gravity of the situation and the roadmap ahead.
Positive Feedback: Stakeholders appreciated the straightforward communication of regulatory needs. Complex jargon was replaced with clear language, fostering a solid project foundation.
Speeding Up Approval: Presenting a robust case was the next step. We highlighted their exclusivity and potential impact on patient safety, making a compelling case for expedited review. Thanks to our meticulous approach, approval arrived faster than expected.
Are you facing regulatory challenges? Let’s work together to overcome them swiftly. In an “Accelerated Regulatory Action Call,” we will:
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Devise tailor-made strategies for your success.
Address your questions and concerns.
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Looking forward to our conversation and the chance to accelerate your regulatory journey!
Best regards,
Aziz