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Case Studies

Type II DMFs

One of our larger pharma clients sought a full conformance review and resulting remediation of 5 of their more important Type II DMFs. Submissions of the associated DMF amendments were needed at the FDA within a 2 month period from project briefing.

Regulink were brought in to help after an earlier gap assessment had been completed, which had not identified certain critical differences.

A detailed granular review was therefore essential against current practice and involved an extensive team of technical and quality SMEs.

The project quickly grew in scope, requiring a flexible response and very adaptable team.

The Solution

The evolving nature of the project as unforeseen non-conformances were observed and additional requests were made, validated the suitability of Regulink’s flexible resourcing model.

The core team was bolstered by further experienced internal and external support, with minimal onboarding and no cost to the client.

Detailed remediation plans were compiled for each submission, to assist the client with their other DMFs in the future.

Highest priority submissions completed in the first round, and the valuable learnings were applied to the later submissions, enabling less client SME involvement and more efficient processing.

The Outcome

The 5 DMF amendments met the target submission date to the FDA, despite the extent of scope drift.

The client is significantly better placed now with its compliant DMFs that are supplied to multiple customers globally.

Clear plans are defined to be applied to the client’s other Type II DMFs so it may meet its conformance objectives.

We want to hear from you.

Do you have similar projects that require flexible support from experienced professionals?

Typically, Regulink can provide its services with a near-immediate start using its industry leading approach. Contact us to find out more.

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