Services
Impurity Qualification Gap Assessment
When impurity strategy drives regulatory decisions, uncertainty becomes risk. Teams are often unsure whether their current PMI qualification and control strategy will withstand regulatory review—during submission, in response to agency questions, or later during pre‑approval inspection.
The Impurity Gap Assessment provides regulatory clarity so your impurity strategy is defensible, proportionate, and aligned with how regulators actually evaluate risk.
We support impurity qualification and control strategies across human and veterinary programs, including:
- Drug substance impurities under ICH Q3A and VICH GL10
- Drug product impurities and degradants under ICH Q3B and VICH GL11
- Mutagenic impurities under ICH M7(R2) and EMA/CVMP/SWP/377245/2016
- Nitrosamines, including risk evaluation, confirmatory testing strategy, and regulatory justification
What we do
A focused, decision‑oriented review of your impurity strategy through a regulatory lens.
We assess what is sufficient, what is vulnerable, and what regulators are likely to question, then help you decide what actually needs to change.
What you get
- A concise gap analysis highlighting real regulatory risks
- Clear recommendations on impurity limits, qualification, and control approaches
- A regulator‑ready justification framework tied directly to guidance and precedent
- A prioritized action list: what to do, and what not to do
How it works
- Targeted kickoff focused on the regulatory decision at hand
- Document review (impurity lists, batch data, stability, methods, risk assessments, agency correspondence)
- Written findings plus a live walk‑through to align on next steps
Scope and timing scale to the decision, not to generic templates.
Who this is for
- Sponsors or manufacturers with an established impurity profile who need regulatory confidence ahead of submission, agency interaction, or site readiness activities.
- Teams facing near‑term decisions on PMI qualification, control limits, or justification strategy, particularly where inspection or global regulator scrutiny is expected.