Strategic advisory and quality project management

Some quality problems are not quality problems. They are business decisions with a GMP and regulatory dimension, and they need someone who can hold both. Our strategic advisory work covers licence applications, site transfers, integrations and remediation programmes, which fail more often on sequencing and governance than on technical content.

A company is applying for its first manufacturing or wholesale distribution authorisation and does not know what the authority will expect to see. A product is moving between sites and nobody owns the quality dimension of the transfer. Two companies have merged and now hold two quality systems, two document sets and two ways of classifying a deviation. A critical inspection finding has produced a remediation programme larger than the organisation has ever run. An electronic quality system is being implemented and the configuration decisions are being made by people who will not have to live with them.

What these share is that the technical answer is usually known. What is missing is sequencing, ownership and a governance structure that makes decisions when they are needed.

We define the target state in terms specific enough to be testable, because “improve compliance” cannot be finished. We sequence the work so that dependencies are respected, since a great deal of wasted effort comes from doing things in an order that requires them to be redone. We put a governance rhythm in place with a decision forum that meets and an escalation path that is used. We keep the regulatory dimension visible, so that a commercial decision made on a Tuesday does not create a licence problem discovered six months later. And we report progress in a form your board can read.

Post acquisition integration deserves a separate mention because it is done badly so often. The instinct is to adopt the larger company system wholesale. That usually produces a system that is disproportionate for the smaller site, which then quietly works around it.

The better route is slower. Establish which elements genuinely must be common, which are usually document control, deviation classification, change control and release. Allow local variation where the operations differ. And set a realistic date, because integration announced as complete before it is complete becomes a finding at the next inspection of either site.

Quality programmes lose board support when the reporting is written in quality language. A board understands exposure, cost, timeline and the consequence of doing nothing. We write status in those terms, with the technical detail available underneath for the people who need it.

This matters practically. Remediation programmes that lose funding halfway through leave a site worse off than if they had never started, because the commitments are now on record and unmet.

Do you manage our staff?

We manage the programme. Line management of your people stays with you unless we have agreed an interim leadership role, which is a different arrangement and is priced differently.

How do you charge for this work?

Usually a day rate against an agreed number of days per month, reviewed as the programme progresses. For defined pieces such as a licence application we can quote a fixed scope.

What is the minimum duration?

Strategic work below about two months rarely produces anything durable. For a single decision or an independent second opinion we do take shorter pieces, and those are often the most useful days a client buys.

Can you help us decide whether to enter a market at all?

Yes, and that conversation is best held before the commercial commitment. The regulatory requirements of a market frequently change the business case, and finding that out afterwards is expensive.

Will you tell us if a plan is not achievable?

Yes. That is a large part of what an independent adviser is for. A plan the organisation cannot resource is worse than a slower plan it can.