Why you should choose PCS for certification support
Certification for the Pharmaceutical Industry
PCS has 33 years of experience in helping individuals and organizations achieve GMP or GDP regulatory compliance and apply for manufacturing and import authorization (GMP) or wholesale distribution authorization (GDP).
PCS will identify the right GMP or GDP requirements, draw up a plan to upgrade your organization, implement this plan and subsequently prepares your entire organization and QMS for regulatory inspection.
You are an individual or company wishing to trade, distribute, store or manufacture pharmaceutical products. Finding the right regulatory requirements is challenging, applying them is even harder. You don’t want to over-do it, nor do you want government inspectors to observe you didn’t do enough.
We help organizations in procuring GMP/GDP certification and associated licenses . The usual process we guide our clients through is detailed to the right.
License process duration
Depending on the type of license you are requesting, the scope of activities you will perform versus the amount of activities you outsource, a typical licensing process takes between six to nine months. Depending on the cooperation of the organization. Furthermore, this could be also delayed as a result of extended inspection deadlines , which could result in additional n months on top of the estimated timeline.
In just 10 steps we help you get licensed
- 1 Connect you to an experienced consultant
- 2 Face-to-face or online meeting
- 3 PCS drafts an action plan
- 4 Offer sent & accepted?
- 5 PCS starts working!
- 6 Apply for a license
- 7 Plan inspection
- 8 Inspection preparation
- 9 Inspection and response
- 10 Licensing*
Why choose PCS' consultancy services?
Which requirements do you have to meet for GDP and GMP certification?
In the Netherlands, licenses are issued by Farmatec. Farmatec provides pharmaceutical licenses, approvals, exemptions and registrations for pharmaceuticals and medical devices for, for example, the pharmaceutical industry.
To avoid delays in the application or change process of a WDA or MIA, it is important to submit applications as correctly and accurately as possible. PCS is happy to help you with this. With the help of years of expertise, we can unburden you by collecting the required documentation, compiling it and submitting it with a correctly completed registration form.
MIA & WDA requirements
In order to meet the requirements for a MIA or WDA, a company must meet a number of requirements;
- The company has implemented the Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) legislation,
- The company may manufacture, distribute, store or import the intended drugs,
- The supply chains have been carefully mapped out and are transparent,
- An inspection can take place at the company; both the quality system and the facility/office are operational,
- A license application is pending with Farmatec (or the company already has a license),
- Must comply with the requirements of the Marketing Authorization or Clinical Trial Authorisation, as appropriate.
More information on licensing in the EU
How can PCS help me in obtaining a MIA or WDL?
Applying for or changing a WDL or MIA license can be complex. In particular, companies that are new to the pharmaceutical industry or want to set up a branch in the Netherlands from abroad can experience the Dutch licensing system as challenging.
PCS has the experience and expertise to guide licensing processes to good results. If desired, PCS can submit the license application to the government and conduct the subsequent correspondence.
What is a GMP certificate?
A GMP certificate is a certificate that shows that your company complies with Good Manufacturing Practice (GMP) and thus meets the requirement of the Ministry of Health to import medicinal products into the EU. If you are GMP certified, you can import and produce medicines.
It also gives your company the ability to manufacture and market medicines in countries. This means that medicines can be sold in the European Union, or that they can be exported to countries outside the EU.
GMP certification: FAQ
What is a GDP certificate?
When a logistics organization is GDP certified, the company is allowed to store and trade medicines. The quality of a medicine must also be guaranteed after the medicine has left the factory. That is why licensing requirements have been drawn up for the storage, transport and delivery of medicines.
The GDP certification is intended for logistics organizations that store medicines for longer than 72 hours, or have outsourced their storage. With a GDP certificate, a company meets the Good Distribution Practice (GDP) requirements. It is not allowed to produce or import medicinal products under a GDP certificate or GDP permit. A GMP certificate and GMP permit are required for this.
GDP certification: FAQ
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