Do you simply want to sell your products successfully?
Without ifs or buts in authorization and marketability?

Leave annoying, regulatory tasks to us

Too much work? Simply outsource!

You have technical know-how and innovative products or excellent customer relationships?

Your human resources in the regulatory departments are scarce or already exhausted due to increased regulatory requirements?

Time-consuming routine tasks and increased documentation requirements worsenes the situation?

You may have already thought about hiring additional staff, but you are not sure whether you will need them in the long term or if this will only result in excessively high personnel costs afterwards. Perhaps you were looking for an employee, but did not find one who met your requirements.

Concentrate on your sales – we take care of the regulatory issues

You are a sales organization, purchasing your products as a private label, and only need to deal with regulatory issues from time to time?

You want to focus on selling your products and not dealing with the regulatory requirements?

You simply want properly approved products with perfect fitting marketing claims?

Then we have the perfect solution for you: Simply outsource your regulatory tasks to MedWiss4you and we will take over your work, whether annoying or time-consuming routine activities as well as documentation and individual tasks and projects, such as a product approval.

Especially for private label products and as an independent service provider, we can assess sensitive data while maintaining confidentiality and carry out a product approval.

  • Medizinische-Wissenschaft
  • Regulatory Affairs und Compliance
  • Projekt- und Produktmanagement sowie Marketing
  • Grafik und Eventmanagement

Transformieren Sie Mehrarbeit und Ideen in Compliance, Innovation und Wachstum

MedWiss4you ist nicht nur Ihre medizinisch-wissenschaftliche und regulatorische Abteilung bei Bedarf, sondern Ihr zentraler Ansprechpartner bei allen Fragen und Aufgaben rund um Hygieneprodukte und Hygiene – aber auch Veterinärprodukte.

Our range of services from A to Z in detail

Medicinal products


Regardless of the size of a company and the turnover with a medicinal product, a pharmaceutical company is obliged to systematically monitor the safety, quality and efficacy of their product. To meet these demands also appropriately qualified and experienced personnel is required.

Label texts, package leaflets and use instructions as well as other product documents or print media for medicinal products must be checked by an information officer with regard to their conformity with the approval and adjusted if necessary. In addition the requirements of the medicines advertising act must also be taken into account for all german marketing materials.

MedWiss4you can assist with the systematic monitoring of your medicinal products and provide the legally required staff, who can take over the following tasks:

  • Taking over the function as an information officer according to § 74 of the german medicines act
  • Creation of specialist texts such as information leaflets, usage information or package inserts as well as label texts including translations
  • Fulfilling the tasks of a graduated plan officer according to § 63a of the german medicines act
  • Implementation and maintenance of a pharmacovigilance system
  • Creation of the pharmacovigilance system master documentation including standard operating procedures
  • Creation of reports (PSUR / PBRER) and statements
  • Literature research
  • Recording, processing and reporting of adverse medicinal product reactions
  • Medical Writing
  • Creation of individual sections or modules for medicinal product approval
  • Performing employee training on pharmacovigilance, advertising messages about medicinal products
  • Support of telephone hotlines, if necessary 24 hours a day


Biocides

Currently in Germany a lot of disinfectants can be registered as biocidal products quite easily within the Federal Institute for Occupational Safety and Health (BAuA). Within Europe requirements for the registration of a disinfectant with not yet approved biocidal active substance are quite different and involve a variable effort, which is normally higher than in Germany.

MedWiss4you supports you with the registration of your biocidal product, whether it is a simple product registration or a more complexe approval project in cooperation with one of our cooperation partner.

  • Worldwide product approval
  • Registration of biocidal products with notified active substances
  • Support in the preparation of approval dossiers with approved biocidal active substances

Approved Active Substances and Product Marketing

Disinfectants with the following approved active ingredients must first undergo product approval before they can be brought onto the market and marketed: iodine, 1-propanol, 2-propanol, peracetic acid, PHMB, iodine, chlorocresol, hydrogen peroxide, sodium and calcium hypochlorite, L -Lactic acid and glutaraldehyde (PT-2).


The current status of the review of the active substances with further details (e.g. the current status depending on the area of application) can be found on the ECHA website:

Chemical safety

Regardless of the approval status of a product, chemicals and products made from them are subject to a wide variety of regulations and laws that must be complied with in order to ensure that the products can be used safely.

Even if associated risks and dangers are communicated along the supply chain, manufacturers and formulators – including distributors and private label recipients – are largely responsible for compliance with legal obligations, but also retailers are subject to various requirements.


  • Creation of a REACH-register
  • Ensuring and documenting of REACH conformity
  • National und european product registration incl. UFI
  • Support with supplier inquiries
  • Evaluation of (extended) safety data sheets
  • Management of safety data sheets und their variants
  • Advice on the classification and labeling of disinfectants
  • Creation and maintenance of a hazardous chemicals register

UFI: Unique Formula Identifier

The so-called UFI is a 16-digit code that must be applied to all hazardous products and enables poison centers to clearly assign a formulation to a product in order to be able to provide more specific advice.


Deadlines


Products for private and commercial use that will be launched on the market for the first time from January 1, 2021 must be labeled with the UFI. Products that are already on the market have a transition period until 1.1.2025.


Attention: Private label users must take into account that they cannot simply use the manufacturer’s UFI code, but need their own UFI.


Cosmetics

MedWiss4you supports the manufacturers and distributors of cosmetic products in all scientific and regulatory issues – we can also provide you with competent assistance with animal cosmetics.

  • Compilation of the product information file
  • Creation of the INCI declaration
  • CPNP Notification
  • Creation of safety reports
  • Support with product claims
  • Advice on and coordination of studies to support advertising claims

Medical Devices

In the field of medical devices MedWiss4you can act as a mutual confidante between the manufacturer (OEM) and the private label recipient (PLM) while maintaining the confidentiality of sensitive data. However, the Medical Device Regulation (MDR) does no longer allow the previous OEM-PLM construct. In the future there are hardly any options for implementing a private label. We would be happy to support you in finding an individual solution.

  • Literature research
  • Creation of the clinical evaluation
  • Proof-reading and/or creation of label instructions and accompanying product documents
  • Examination of advertising documents for conformity with the approval and legal requirements
  • Creation of the technical documentation
  • UDI registration

The end of the transition period for medical devices – are you prepared?

The transition period for the “new” Medical Devices Regulation (MDR) ends on May 26., 2021 – with a postponement of one year – and from then a private label in its current form is no longer possible. This is due to the obligation, that the private label recipient needs to have acess to the technical documentation in order to meet the requirements of the MDR for post-market surveillance and medical device vigilance.


The new requirement to label medical devices with the UDI code, whose deadline has been postponed by 2 years, is attracting a great deal of attention.


It should not be forgotten, however, that additional labeling requirements must be taken into account: For example, more extensive information on the safe use of the product must be given in the instructions for use, which in case of disinfectants often correspond to the product information. However, other details such as the identification of changes in these documents or the explanation of pictograms used, must also be taken into account.


If you have been using a private label, remember not to simply change the manufacturer specification when converting your disinfectant – information on labels, instructions for use or product information must match those of the manufacturer and meet the new requirements.

You are missing a particular regulatory task in the list? Then we look forward to talk to you about this. Just give us a call, write an email or use the contact form or our appointment scheduling tool to arrange a personal meeting. We will give you a feedback as soon as possible, whether and to what extent we can support you in the desired task. We look forward talking to you!