Registration and authorisation of medicinal products and nutritional supplements

1Q Health has extensive experience and in-depth knowledge in the registration of nutritional supplements and the authorisation of pharmaceutical products. The right authorisation strategy starts with the selection of raw materials and development – areas in which we have proven expertise. For many years, we have successfully supported our customers in the timely development and market launch (including authorisation and registration) of effective, high-quality products, thereby making an important contribution to a healthier life for patients and consumers worldwide.

Nutritional supplements

Registration as the start of your success story

Mastering the legal and organisational tasks (regulatory affairs management) is a major task in which we are happy to provide you with professional support. We help you select marketable raw materials and develop the desired formulation. In addition to our established white-label products, we are also happy to fulfil individual customer requests (private label). The authorisation strategy of our regulatory affairs management includes the following services:

Registrierung als Beginn Ihrer Erfolgsgeschichte

Formulation development

Sensible combination of raw materials
Support in the selection of ingredients for nutritional supplements and pharmaceutical products

Raw material testing

Updating and checking of specifications
Verification of certificates of analysis

Marketability tests

Compliance with maximum quantities
Differentiation between nutritional supplements and pharmaceutical products
Testing of novel foods (Novel Food Regulation)

Analyses

Advice and explanation of analyses (results) for microbiology, heavy metals, pesticides and other parameters
Active ingredients analysis and assurance

Label check

Ensuring compliance with LMIV, FPackV and other laws and regulations
Checking of health claims

Customer advice

Answering raw-material-specific questions
Clarification of food law issues
Advice on the authorisation strategy

Pharmaceuticals

Arzneimittel: Die passende Zulassungsstrategie

The right authorisation strategy

The requirements for the authorisation and registration of medicinal products have been significantly tightened in recent years, both within and outside the EU. This has made the selection of the right authorisation strategy more important than ever, and is decisive for the success or failure of a product (regardless of whether it is a nutritional supplement, pharmaceutical or medicinal product). Our specialists take all relevant aspects into account during development and ensure compliance with the applicable safety and efficacy requirements at the highest level. 1Q Health supports its customers not only during, but also after marketing authorisation with the submission of change notifications and stability data.

Highest standard for nutritional supplements and pharmaceutical products

All our sites are of the highest technological standard and have IFS, ISO, organic, HACCP certification and/or the EU GMP standard, as required. As a contract manufacturer, Q1 Health is always interested in further development and opening up new markets, and is therefore open to the conducting of audits by authorities or adapting to local requirements.

The customer is always at the centre of everything we do. Thanks to our broad-based expertise, we can help you find the best authorisation strategy for your medicinal product, nutritional supplement or pharmaceutical product and bring it to market promptly and in the highest quality.