RegOpsPro™

GDP consulting support

Practical, proportionate support for organisations that need additional help applying, reviewing or strengthening GDP arrangements. RegOpsPro remains a free self-service platform; consulting is available where independent review or implementation support would be useful.

Discuss your requirement Contact and confidentiality

Use the platform first if it meets your needs. Consulting is optional. The assessments, operating models, guides and tools can be used independently, and platform inputs are not automatically shared with the consulting service.

Where additional support may help

Support can be scoped around a specific issue, review or implementation need rather than a broad consultancy package.

WDA(H) readiness

Licence-scope review, gap assessment, quality-system readiness and preparation for new applications or material operational changes.

GDP quality systems

Governance, SOP architecture, deviations, CAPA, change control, management review, recalls, returns and record design.

RP and RP-I governance

Role definition, delegation, deputy cover, escalation, decision records and import-assurance arrangements within the wider GDP system.

Supply-chain assurance

Supplier, customer and 3PL qualification; quality agreements; temperature controls; transport risk; and outsourced-activity oversight.

Inspection readiness

Independent review, evidence retrieval, mock challenge, remediation planning and preparation of the accountable team.

GDP remediation and improvement

Prioritisation of findings, repeat-event analysis, CAPA effectiveness, risk registers and sustainable control improvements.

Practical, proportionate support

Consulting is intended to complement the RegOpsPro platform where an organisation needs independent challenge, additional capacity or help translating an identified gap into an implementable GDP arrangement.

Start with the free platform

Not every organisation needs consultancy. RegOpsPro’s free assessments, operating models and toolkits can be used to understand the current position, identify gaps and decide whether any additional support is required.

Assess GDP maturity

Establish a structured baseline and identify priority improvement domains.

Start the assessment

Review role governance

Explore the RP and RP-I operating models, responsibilities, interfaces and evidence expectations.

Explore operating models

Test practical controls

Use the toolkits and inspection workflow to structure outputs and expose implementation gaps.

Explore free toolkits

Optional starting point: GDP Governance Review

A focused independent review for organisations that want a clearer view of their GDP governance arrangements and the areas that may warrant attention. It is not required before using other consulting support.

Review

Agree a defined scope and consider the relevant governance arrangements, controls and evidence.

Findings

Summarise strengths, vulnerabilities and priority gaps in the context of the organisation’s licence and operating model.

Priority actions

Set out a proportionate sequence of actions. Any further implementation support remains optional and separately scoped.

Ways to engage

Support can be kept focused and proportionate to the need.

Focused review

A defined assessment of one control area, distribution route or regulatory issue, with findings and recommended actions.

Readiness or improvement support

Structured support for a WDA(H), GDP-system build, remediation programme, import route or inspection milestone.

Ongoing advisory support

Periodic independent challenge or GDP input where an organisation finds this useful.

RP and RP-I support can also be scoped where required. This may include ongoing, interim or transitional arrangements appropriate to the licence and operating model.

What happens after you contact us

The aim is to keep any engagement proportionate. A platform finding does not automatically become a consulting project.

1. Clarify

Start with a high-level discussion of the issue, context and desired outcome. Do not send confidential records at this stage.

2. Scope

Decide whether external support is actually useful and, if it is, agree the smallest practical scope, deliverables and boundaries.

3. Deliver and hand back

Review, challenge or implementation support is documented so actions, ownership and outputs can be taken back into the organisation’s controlled QMS and governance arrangements.

Discuss a specific requirement

If the free platform has identified an area where additional help would be useful, send a short high-level summary of the issue, desired outcome and timeframe. Please do not send confidential records or personal information with the initial enquiry.

Email consulting@regopspro.com