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Pharmaceutical consulting

Our pharmaceutical services

Consulting services and QP services

support pharmaceutical industry customers with extensive consulting services that also include comprehensive 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.

We also support 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.

QP services

Our QP services are crucial when launching products onto the market: we provide you with experienced Qualified Persons as per Section 15 of the German Drug Act (AMG).

The services provided by the Qualified Person enable you to meet your legal obligations as a pharmaceutical company. These also include batch certification and release with QP certification. We create all GMP-relevant documents and perform 3rd party audits for our national and international customers.

Our services

  • Assuming responsibility as a Qualified Person (QP) according to Section 15 AMG
  • Batch certification with QP attestation
  • Manufacturing authorisation according to Section 13 AMG for the testing and approval of drugs
  • Execution of 3rd party audits
  • Creation of GMP-relevant documents (PQR)
  • Support in establishing and further developing QM systems

Regulatory affairs

We 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) 

Full range of services for your company

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.

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