MIA & WDA Licensing: From Application to Authorisation
PCS engages when an MIA or WDA application needs to deliver more than a one-off pass. We build the underlying quality system so it operates from day one of authorisation — embedding the behaviours your QP, RP and line management will rely on through every subsequent inspection.
When this is the right fit
PCS engages with executive sponsors of licensing projects when:
A new MIA or WDA must be obtained within 6–12 months to support a commercial commitment, contract award or market entry
A scope change (new product type, import activity, manufacturing process or site) requires a licence variation and the existing quality system was not designed for it
A previous MIA or WDA application has been rejected, withdrawn or returned with significant conditions
The licensing inspection is scheduled and the named QP or RP is new in role or new to the site
You are entering the EU market for the first time and need to align operations to EU pharmaceutical authorisation expectations before the competent authority sees them
When this is not the right fit
When you should look elsewhere
- You need a paperwork-only application package and do not intend to change how the operation runs
- You expect the licensing inspection to pass without engaging your QP, RP or operational management with us
- You are seeking the lowest day-rate option — licensing programmes are led by senior partners with regulator-facing experience
- You have no executive sponsorship to act on findings that affect facility design, headcount or processes
What you get
Each deliverable moves you closer to a successful authorisation with minimal rework and regulator pushback.
Licensing Gap Assessment
A thorough comparison of your current state against MIA or WDA requirements. We map every gap to specific regulatory references and rank them by criticality so your investment targets the right areas first.
Quality System Documentation
Development or revision of your QMS documentation to meet the scope of your licence application. This includes the site master file, key SOPs, quality manual, and procedural framework aligned to EU GMP or GDP guidelines.
Application Dossier Support
Guidance on assembling and reviewing the licence application dossier, including facility descriptions, process flows, organisational charts, and supporting evidence that regulators expect to see.
Inspection Preparation & Coaching
Mock inspection sessions tailored to the licensing scope. We coach your team on how inspectors evaluate new licence applications and what evidence they request during the initial site visit.
Post-Authorisation Compliance Support
Once authorised, we help establish ongoing compliance monitoring, change control procedures for licence variations, and annual review processes to maintain your authorisation without gaps.
How we work
Licensing timelines vary by scope and starting position. We offer three engagement formats to match your situation.
4-8 weeks
For organisations with an existing QMS that needs alignment to licence requirements
Typical deliverables
- Gap assessment against MIA/WDA requirements
- Documentation revision and alignment
- Inspection coaching for key personnel
3-6 months
Complete licensing support from quality system build to inspection readiness
Typical deliverables
- End-to-end QMS development for licence scope
- Application dossier preparation and review
- Multiple mock inspection rounds and remediation cycles
Ongoing
Continued support through post-authorisation and licence maintenance
Typical deliverables
- Licence variation and change control support
- Periodic compliance reviews and readiness checks
- Regulatory intelligence on guideline changes
Typical timeline
Assessment & Planning
We evaluate your current quality system and operations against the specific MIA or WDA requirements. You receive a detailed gap report with a phased action plan, realistic timelines, and resource estimates within the first two weeks.
System Build & Documentation
Quality system elements are developed or revised to meet licence requirements. Documentation is created in parallel with process implementation so your system is genuinely operational, not just written down.
Inspection Readiness & Submission
The application dossier is finalised and your team is prepared through mock inspections. When the licensing inspection takes place, your site, people, and documentation present a consistent and compliant picture.
What clients see
Example (anonymised)
A logistics company expanding into pharmaceutical wholesale needed a WDA from scratch. PCS built the complete GDP quality system, prepared all application documentation, and coached the operational team and named RP through a mock inspection programme. The licensing inspection was completed successfully on the first attempt with no critical findings.
See more clients and outcomes →"We had no pharmaceutical background. PCS built our quality system, trained our team, and walked us through every step. We received our WDA on the first application."
Frequently asked questions
A Manufacturing and Import Authorisation (MIA) covers the manufacture, assembly, and import of medicinal products. A Wholesale Distribution Authorisation (WDA) covers the storage and distribution of medicinal products. Some organisations need both depending on their activities. We support either or combined scopes.
From project start to authorisation, timelines typically range from 4 to 9 months depending on your starting position, scope complexity, and the competent authority's processing time. Organisations with existing quality systems move faster.
Yes. We analyse the reasons for rejection, develop a targeted remediation plan, and prepare you for re-application. Our experience with licensing inspections means we understand what regulators look for and where previous applications commonly fall short.
We support MIA and WDA applications across the EU. While regulatory frameworks are harmonised under EU legislation, each competent authority has specific procedural requirements. We adjust our approach accordingly.
MIA licences require a named Qualified Person; WDA licences require a Responsible Person. We can advise on QP/RP requirements and, where needed, provide interim QP or RP services to support your application.