01First Call
In a free 30-minute call you tell us what you need, for which sites and by when, and we tell you how we would run it.
Inspected at the source,trusted to the end.
We audit suppliers and build quality systems for pharmaceutical and medical cannabis companies, from the cultivation site to the EU GMP market.
Long-term success in the medical cannabis industrydepends on an effective Pharmaceutical Quality System.
- Importing flower or extracts into the EUEU GMP supplier qualification
- Auditing a supplier, a CMO or your own siteIndependent EU GMP and GDP audits
- Growing cannabis for medical useGACP cultivation compliance
- Selling to EU GMP buyersFrom GACP to EU GMP
- Building or fixing your quality systemPharmaceutical Quality System
- Running quality without a QA teamFractional QA
- Training your people on GMP, GACP or GDPTraining
How we work
Audit or project, we take every engagement through the same six steps.
- 01
- 02
Scope & Quotation
We write down the criteria, the sites, the phases and what you will receive, and you approve the quotation.
- 03
Review & Gap Assessment
Before an audit we review the site’s documents and history, and before a project we measure your system against the standard you work to.
- 04
Planning
We turn the scope into an audit plan or a project plan in phases, with dates agreed with you.
- 05
Execution
We audit on site or remotely, or we write the documents, train your people and work beside your team until it runs the system on its own.
- 06
Delivery & Follow-Up
You receive the audit report and, when in scope, our review of the CAPA, or the finished system with an internal audit before the certification audit or the inspection.
The latestfrom our CEO.
Riccardo Longato, Chief Executive, on the regulatory and market questions in the medical cannabis supply chain.
Explore all videosThird-party sources that name Clear
You know what it costs and what you receive.
Audits
per site
From the preparation to the report
Projects
per phase
GACP, GACP to GMP and PQS, each phase with its deliverables
Fractional QA
per month
A retainer on a scope agreed in writing
Training
per course
With the material and the training records
Would you rather talk it through first?
Questions clients ask us before we start.
We do both, on GACP, EU GMP and GDP. On a single site we do one or the other, because we do not audit a site we have advised, and we do not advise a site we audit.
Yes, the report gives your qualification file independent, traceable evidence, while your Quality Unit keeps the approval decision, the supplier status and any conditions under your Pharmaceutical Quality System.
The EMA GACP guideline asks the buyer to audit the grower’s sites and describes no certificate, so your EU buyer will send auditors whether or not you hold one. We prepare your site for those audits and, if you choose a certification body, for its audit too.
The manufacturer who uses the material designates the point, documents it and gives the reason, as EU GMP Part II section 1.2 requires, with the risk method of ICH Q9. We map that point with you and build the file buyers now ask for.
We set the phases and the dates after the gap assessment, because they depend on what your site already has in place and on when your buyer or your certification body audits you.
Yes, with Fractional QA on a monthly retainer. Within the scope we agree, we handle deviations, investigations, CAPA, supplier scorecards and the QA review of incoming consignments.
Yes, for document work, Fractional QA and training. For each audit we choose with you between on site, remote and hybrid, knowing what a remote audit cannot show you.
Yes, on site or online, from EU GMP fundamentals to data integrity, internal auditing and AI in GMP. Each course ends with training records and a check of what people learned.
We do not act as Qualified Person or Responsible Person, run validations or test samples in a laboratory.
We confirm the detailed scope and the contractual points before the engagement.
