Do you have specialist know-how and innovative products or excellent customer relationships?
But due to increasingly stringent regulatory requirements, are your personnel resources in the relevant departments scarce or already exhausted?
Time-consuming routine tasks and an increased documentation effort further complicate the situation?
Perhaps you have already thought about hiring additional staff for this purpose, but you are not sure whether you will need them in the long term and whether this will not result in too high personnel costs later on. Perhaps you have been looking for an employee, but have not found one who meets your requirements.
Are you a sales organization that sources your products as private label and only have intermittent needs to handle regulatory issues?
Quite independently of this, would you actually prefer to concentrate on selling your products and deal less with regulatory requirements? Because you actually only want products that are properly approved and optimally advertised for distribution?
Then we have the perfect solution for you: Simply outsource your regulatory tasks to MedWiss4you and we will take over your work, whether tedious and time-consuming routine activities, documentation tasks or individual tasks and projects, such as product approval.
Particularly in the case of private label products, as an independent service provider we can assess sensitive data while maintaining confidentiality for the private label taker and carry out product approval.
Regardless of the size of a company and the sales of a drug, the pharmaceutical entrepreneur (PU) is obliged to systematically monitor the safety, quality and efficacy of its drug. In order to fulfill these requirements, appropriately qualified and experienced specialist personnel are also required.
Label texts, technical information and instructions for use, as well as other product documentation or print media for medicinal products, must be checked by an information officer with regard to their conformity with the marketing authorization and adapted if necessary.
In addition, all marketing materials must also take into account the requirements of the Therapeutic Products Advertising Act. MedWiss4you will be pleased to support you in the systematic monitoring of your medicinal products and provide you with the specialist personnel required by pharmaceutical law who can perform the following tasks for you:
In Germany, many disinfectants can currently be registered quite easily with the Federal Institute for Occupational Safety and Health (BAuA) as biocidal products. In Europe, the requirements for registering a disinfectant with a biocidal active ingredient that has not yet been approved vary widely and involve a variable amount of effort that is generally higher than in Germany.
MedWiss4you supports you in the registration of your biocidal product, be it a simple product registration or a more complex registration project in collaboration with one of our cooperation partners.
Visit our dedicated website to find out how we can help you get your biocide product approved and save you money:www.smart-biocides.de
Regardless of a product’s approval status, chemicals and products made from them are subject to a wide variety of regulations and laws that must be complied with to ensure safe use of the products.
Even though the communication of the associated risks and hazards takes place down the supply chain in particular, and thus manufacturers and formulators – including distributors such as private label takers – are largely responsible for compliance with the legal obligations, distributors are also subject to various requirements. We are happy to support you in complying with chemical legal requirements:
MedWiss4you supports manufacturers and distributors of cosmetic products in all scientific and regulatory matters – we can also provide competent support for animal cosmetics.
In the field of medical devices can MedWiss4you under protection of confidentiality of sensitive data as common confidant between manufacturer (OEM) and private label taker (PLM) function. However, the Medical Device Regulation (MDR) no longer allows the previous OEM-PLM construct in its form. In the future, there will only be a few options for implementing a private label. We will be happy to support you in finding an individual solution.
Our passion is to give our best day after day to realize our customers’ ideas and visions for safe and effective hygiene products.
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