Pharmaceutical consulting at WESSLING

WESSLING supports pharmaceutical industry customers with extensive consulting services that also include comprehensive QP services.

Drug ampoules for pharmaceutical consulting and QP services

Our aim is to find holistic solutions to our customer's challenges and issues in the field of pharmaceutical consulting. Analytical questions concerning pharmaceutical raw materials and preparations are answered by our competent specialists in our GMP-certified laboratory. We create trust in your drugs thanks to our reliable laboratory analyses and expertise.

WESSLING also supports you with highly competent pharmaceutical consulting and analyses in maintaining and ensuring product quality and legal requirements – equating to the optimisation of your costs. If required, we can provide you with complete project support and advise you on your analytical and galenical questions.

Our services in detail

Regulatory Affairs

Regulatory affairs: registration dossiers for medicinal products

WESSLING supports you in finding the appropriate approval strategy and also in national and EU approval procedures (mutual recognition procedures (MRP), decentralised procedures (DCP)).

During these procedures the regulatory authority reviews the safety, quality and efficacy of a medicinal product. Upon receipt of marketing authorisation, the marketing authorisation holder (MAH) is allowed to market a particular medicinal product in one or more EU Member States. After approval has been granted, our pharmaceutical experts at WESSLING also support MAHs in the lifecycle management of their products and take over the maintenance and updating of documentation (renewals and variations).

Preparation of registration dossiers

A registration dossier contains all the information required by law on a medicinal product. WESSLING takes on this task for producers of medicinal products and prepares this registration dossier. For this purpose, we compile all necessary information on the individual dossier modules in CTD format (common technical document).

We also support you in preparing registration dossiers for investigational medicinal products (IMP).

An overview of our services:

Strategies and support in regulatory matters
Assistance in national and EU approval procedures (MRP/DCP)
Preparation of registration dossiers (including IMPD)
Support in the maintenance and updating of approval documents (variations and renewals)

Your contact

We will be happy to support you.

Your contact for the topic of pharmaceutical consulting

„Our pharmaceutical consulting is always goal-oriented: you want to launch a product onto the market, we support you with a range of services in which consulting and analysis are perfectly matched. “

Pharmaceutical Analysis at WESSLING: Complete solutions for pharmaceutical manufacturers and pharmaceutical companies

If necessary, we supplement our consulting services with analytical components. Our laboratory has a manufacturing authorisation according to Section 13 AMG for the testing and approval of drugs.

Our laboratory site additionally have an EU import permit for drugs from non-EU countries. This enables us to perform approval tests with QP certification for our customers.

WESSLING offers you a full range of services from one source, also for consulting and expert reports for cosmetics.

Burkholderia ceparia in pharmaceuticals

Burkholderia cepacia is a bacterial species of increasing importance for the pharmaceutical, OTC and cosmetics industries. The WESSLING experts for pharmaceutical analysis have successfully established the USP methods in their laboratory. They analyse process water, starting substances and end products for contamination with Bcc according to USP specifications.

Langzeit-, Kurzzeit- und In-Use-Stabilitätsprüfungen

The WESSLING pharmaceutical experts perform stability tests and storage on finished medicinal products, medical products with pharmaceutical content and active substances as per the current ICH and GMP specifications. We check the stability-relevant parameters, content, purity and release of active substances and prepare test plans, overview tables for stability tests and individual stability reports.

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Pharmaceutical analysis equipment

In Münster, we analyse your medical products and drugs using the latest analysis technology. Would you like to find out more about the equipment at our laboratories? Here, you can find out about the laboratory analysis facilities and equipment in detail.

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Medicinal cannabis and cannabis products

WESSLING has the required GMP certificate and the narcotics permit enabling it to test cannabis flowers according to the German Pharmacopoeia as regards identity, content and purity. We use HPLC and suitable reference substances to determine the precise concentrations and components of the drug. With manufacturing authorisation according to Section 13 AMG, WESSLING also supports importers of pharmaceutical cannabis in the approval of drugs. Together with our logistics partners, we can also undertake the entire pharmaceutical service chain package.

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Burkholderia ceparia complex (Bcc) 1 / 4

Medicines in GMP laboratory of WESSLING for pharmaceutical analysis

Pharmaceutical analysis at WESSLING

In GMP-certified and FDA-inspected laboratories, WESSLING provides fast, professional and reliable services on the subject of safe pharmaceuticals and pharmaceutical analysis.