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GMP & GDP Licensing Support Services

Support from A-to-Z in helping you obtain a Manufacturing & Import Authorization or Wholesale Distribution Authorization.

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Over 100 satisfied clients preceded you!

Why you should choose PCS for certification support

Our services are worldwide,
We have a 98% success rate in getting clients GMP or GDP certified,
We usually respond within the hour,
Full support in 1 to 3 days.

Certification for the Pharmaceutical Industry

PCS has 34 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.

Julian Koster, Business Development

Curious to see how we can help you get certified? Plan a free consult today!

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Become certified

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.

Licensing process

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?

Extensive experience in regulatory inspections and audits,
Our consultants are ex-regulatory inspectors and industry experts, having conducted more than 300 audits each,
Thanks to our international clients we can prepare clients for every regulatory inspection; EU GMP, U.S. FDA, WHO GMP or a combination of these regulatory frameworks,
We know what your clients or the government expects and inspects!
Julian Koster, Business Development

Let me help you explore all the benefits of our services!

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Which requirements do you have to meet for GDP and GMP certification?

To be able to manufacture, distribute or import medicines your company needs a Manufacturing and Import Authorization (MIA) or a Wholesale and Distribution Authorization (WDA).

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
Good Manufacturing Practice (GMP) is a quality standard for the manufacture of pharmaceuticals. GMP ensures that pharmaceutical manufacturers must always follow the same quality requirements. Manufacturers are tested against GMP by governments.
Manufacturers of medicines and active substances must have a GMP license and GMP certificate. Importers of medicines to the European Union must also have a GMP license and GMP certificate.
Outside the EU, national governments regulate the GMP certification of manufacturers. For example, countries such as Japan, Canada and China have their own GMP.
In the United States, the United States Food and Drug Administration (U.S. FDA) issues permits and certificates. On a global level, medicines are purchased by the World Health Organization (WHO). The WHO has set up its own GMP regulations and certification. In order to be allowed to supply medicines to the WHO, companies must go through WHO prequalification (WHO PQ) and comply with the WHO GMP.
As a rule, a GMP certificate is valid for a maximum of 5 years. There may be reasons for the Health Care and Youth Inspectorate to issue a GMP certificate with a shorter period of validity. Before the validity period has expired, the IGJ will carry out an inspection. In this it is assessed whether the manufacturer/importer still complies with the GMP and the requirements of the registration dossier.

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
Medicines in the EU come from all over the world. Transport involves risks. To limit these risks, the European Commission has drawn up the Good Distribution Practice (GDP) guidelines. The GDP ensures that distributors of medicines do this safely. Distributors subject to the GDP guidelines are assessed by the government against the GDP guidelines and requirements.
Logistics companies must comply with GDP requirements. These apply to the entire distribution chain of medicines and active pharmaceutical raw materials within the European Union. If you only transport medicines, without storage, you can voluntarily apply the GDP requirements to your transport activities. Distributors and wholesalers who store and distribute medicines for longer than 72 hours are required to obtain a wholesale license and GDP certificate. Outside the EU, the GDP requirements are less specific. There is no separate GDP guideline in the United States. National governments do, however, enforce principles comparable to the principles of the EU GDP. Think of quarantine requirements, pest control and temperature controlled transport.
GDP certificates have a maximum validity of five years. In some cases, a GDP certificate with a shorter validity period is issued by the Health Care and Youth Inspectorate (IGJ). As a rule, the IGJ carries out a GDP inspection of the wholesaler for the certificate. This inspection can take place at any time towards the end of the GDP certificate.

Have a question about licenses?

We’re here to help! We usually respond within 1 hour or business day.

We help companies worldwide,
We have a 98% success rate,
Experienced, ex-EU GMP/GDP inspectors as consultants,
We respond to licensing support requests within the hour,
We take care of the entire licensing process,

Contact us

We have the expertise and experience to help you obtain a MIA or WDL!

Riekert Bruinink
Riekert Bruinink

Senior GMP & GDP Consultant

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Available M-F: 09:00 AM to 5:00 PM

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