We about us
Chem Affairs Deutschland GmbH (CAD) is an international consulting company based in Syke, on the outskirts of the city of Bremen. Our main area of business is in the pharmaceutical industry. We can support you regarding theoretical questions and practical solutions. Our multilingual staff with offices in Germany and in China is at your service.
CAD, your reliable pharmaceutical Consulting Team!
Supplier Audits according to the
ICH, US or EU GxP guidelines
We offer a comprehensive GMP Audit Expertise Across the Pharmaceutical Value Chain. Our audits span a wide range of technologies, product categories, and regulatory risk profiles — delivered with consistency and confidence at both national and international level.
Active Pharmaceutical Ingredient (API) Manufacturers
- Chemical, hormonal, antibiotic, and genotoxic APIs
- Anticancer products and partially sterile API manufacturing
- Manufacturers of Traditional Chinese Medicine (TCM)
- Tea and herbal product manufacturers
Chemical Products & Pharmaceutical Intermediates
- Chemical raw materials
- Pharmaceutical intermediates
Primary & Secondary Packaging Materials
- Sterile and non-sterile packaging materials
- Printing companies (labels, package leaflets, packaging components)
Finished Dosage Form Manufacturers
- Tablets, hard and soft capsules
- Gels and creams
- Specialized expertise in sterile injectables
Additional Product Categories
- Excipients
- Food supplements
- Sugar substitute products
Logistics & Distribution
- API transportation providers
- Finished product logistics and distribution companies
Audits are conducted in German, Chinese, English, Japanese, and Italian, ensuring effective communication and culturally aware audits worldwide. Name your supplier — chances are we have already audited them. And if not, we know exactly what to focus on. Contact us today for a non-binding consultation.
Pharmaceutical Manufacturers of Injectables
Pharmaceutical safety standards for the manufacture of sterile injectables and vaccines are extremely demanding. Preparing a facility to meet these requirements is complex and time-intensive — and requires experienced hands-on-expertise.
We provide highly qualified consultants who can be deployed on site for one to two weeks at a time, and, if required, over multiple assignments.
Our experts are trained to assess and implement
- Assessment of cleanroom classifications and environmental requirements
- Development and review of SOPs and GMP-relevant documentation
- Preparation of Contamination Control Strategies (CCS)
- Planning, execution, and evaluation of Aseptic Process Simulations (Media Fills / APS)
- Practical GMP support for sterile manufacturing operations
Furthermore, we offer GMP training seminars with examinations for:
- Quality Assurance (QA)
- Quality Control (QC)
- Production Personnel
We provide qualified personnel, GMP-compliant documentation, and targeted training in German, English, and Chinese — tailored to your facility and regulatory goals.
Don’t hesitate to contact us for a preliminary assessment.
Contract manufacturing in China
Production Transfer & Relocation Support
There are many reasons why pharmaceutical companies choose or are required to relocate manufacturing activities abroad. When production needs to be transferred, CAD provides comprehensive support to ensure a smooth, GMP-compliant, and efficient transition.
We support the transfer of analytical methods and manufacturing processes, including the preparation of all required GMP documentation and procedures. Our experienced and appropriately trained consultants are present on site at the new manufacturing location to closely monitor production and analytical activities until both manufacturing and quality control operate reliably and in full compliance.
On-Site Oversight & Regulatory Assurance
Following completion of all required qualifications and validations, we remain on site during the initial production batches to:
• Supervise manufacturing operations
• Review analytical test results
• Confirm the corectness of the GMP-relevant documentation
• Furthermore, our Qualified Staff will verify and countersign GMP documentation which is submitted to Germany, before the products are released for shipment to Germany and the European market.
If you are considering relocating production, we recommend contacting us at an early stage. We help you minimize regulatory risks and ensure a controlled transition.
Support for Existing Overseas Manufacturing
If you already manufacture abroad and product quality does not meet expectations, we can also provide experienced personnel to support operations, identify gaps, and restore GMP-compliant manufacturing and quality systems.
Contact us to discuss your production relocation or optimization project.
Registration of Pharmaceutical Products and Medical Devices
If you are interested in any detail about obtaining marketing authorization for your own pharmaceutical products in one or more EU Member States, we would be pleased to support you throughout your project.
Matchmaking with Chinese Partner Companies
Our Lead Auditors began their GMP training in Australia in 2000. Shortly after relocating to China, we started conducting supplier audits for the German pharmaceutical industry. Since then, we have worked with a wide range of suppliers exporting their products to Germany and Europe.
At the same time, our involvement in preparing Chinese manufacturing sites for EU GMP inspections brought us into close contact with the top management of numerous companies. It should also be noted that the key personnel in Germany and China have been working with CAD for nearly 20 years.
Based on this background, CAD has built an extensive network of contacts, enabling us to identify and recommend the most suitable partner company for your needs.
If you require further information, we would welcome the opportunity to discuss your project.
PDE Reports
To register a pharmaceutical product on the European market, a large amount of data must be submitted to the relevant regulatory authorities. This includes several expert reports. These expert reports must be accompanied by a signed curriculum vitae, including certificates that demonstrate the expert’s academic qualifications, continuous professional training, and relevant experience.
Our experts have access to all relevant toxicological databases and possess the required academic qualifications and professional experience to prepare these toxicological reports for your active pharmaceutical ingredients (APIs) and finished pharmaceutical products. As the amount of information to be assessed and the length of the resulting report can vary significantly depending on the API and the finished product, a standard price cannot be offered.
If you are interested in obtaining such a report, please provide us with the product details so that we can prepare a quotation.
Seminars & Training
The following seminars or webinars can be delivered:
- Disaster control
- EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, new Annex 1 (2023): Manufacture of Sterile Medicinal Products (ENG)
- How to prepare a “Media Fill” report (Aseptic Process Simulation; APS)
- How to create a Contamination Control Strategy (CCS)
In addition, we have access to a wide range of further SOPs, documents, and practical training sessions. If you have any questions about other seminars or training courses, please feel free to contact us.
We look forward to supporting you with seminars, practical training units and examinations.
Exhibitions and Trade Fairs
We regularly attend CPhI Europe and CPhI Shanghai. Please do not hesitate to contact our office in Germany if you are interested in meeting with us.
