Looking for more information about CMC Sweden? CMC is short for Chemistry, Manufacturing, and Controls. It is more widely known as a bigger part of the preclinical and early to late development of a new product, drug, or material. To assure that your new product is completely secure, reliable and compliant, you should comply with the guidelines governing CMC in Sweden and EU/US.

Gathering and analysing information with CMC Sweden

When creating and manufacturing a new product or material for the market, the substance is first subject to preclinical testing, where basic knowledge about the chemistry, manufacturing routes and controls are established. Before the production of a new material can begin, you must gather the right and proper information by using phase adaptable approach to CMC in Sweden as well as in EU/US. Once you have the proper information you will be sending results to the regulatory authorities, such as the Medical Products Agency, to get approval for the clinical trial in question or the Market Authorization of such product.

You must therefore optimize the substance, material, or drug to be able to closely examine and analyse the material in question, by submitting it to several tests. After your substance/product has been to trial, you will then be able to manufacture you new product with the right guidance and certifications for the propagation in the development chain or leading to a New Drug Application

Why following the CMC in Sweden is crucial to your production?

When creating a new material, a drug, or a substance you will have to be certain of its quality and its safety. CMC Sweden is an important step in securing your product before it goes into production, during clinical trials and before you are distributing it out into the world. It is a compliant measure, and a necessity for both your company and to your overall success for the intended medicinal product.

By closely following the measures for CMC Sweden, it will lead to complete certainty and reliance on your manufacture procedure and in your product. ClinStorage bring you the right expertise in the area of CMC.

 

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