Error: Contact form not found.

Contract Manufacturing of Medical Products

Contract Manufacturing of Medical Products

Instead of investing in their own production resources or workforce, it is worth considering outsourcing the production of a product to a contractor. Contract manufacturing of medical products is an opportunity for pharmaceutical companies to reduce costs and focus on other aspects. It is an increasingly common and conscious practice for companies that incorporate private label services into their development strategies. According to studies in 2016, nearly two-thirds of produced drugs were developed by contract manufacturers. What are the benefits of collaborating with entities engaged in contract manufacturing?


Medical Products - Definition and Legal Aspects

According to the definition in EU law, a medical product is any tool, apparatus, device, reagent, material, or other article intended for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases or disabilities. It is a broad concept, and medical products include items such as hearing aids, contact lenses, inhalers, pregnancy tests, prosthetics, and serological tests. Medical products also include items similar to medicinal products that support treatment – unlike drugs, they cannot exhibit pharmacologically dependent effects. Medical products include throat pain preparations, lozenges, syrups, aerosols, and eye moisturizing drops.


Contract Manufacturing of Medical Products - Legal Regulations

It is worth noting that in Poland, medicinal products are supervised by the President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. For their registration, a medical product must have a declaration of conformity and a document confirming compliance with EU regulations. The declaration of conformity entitles the manufacturer to label the product with the CE mark (Conformité Européenne). Every entity engaged in contract manufacturing of medical products should adhere to Good Manufacturing Practice (GMP) and provide services in accordance with the requirements of the HACCP system and PN-EN ISO 13485:2016.


Scope of Collaboration in Contract Manufacturing of Medical Products

The added value for medical entities and pharmaceutical companies seeking support lies in the comprehensive services offered by companies providing outsourcing in the production of medical products. In our company, Adex Cosmetics&Pharma, we have an innovative machine park, a team of experienced technologists and experts from various fields, and two dedicated laboratories. With rich technological and personnel resources, we can offer professional contract manufacturing services for medical products. A comprehensive approach relieves the client, allowing them to entirely delegate the production process to the contractor, reducing costs and saving time. We analyze the client’s needs, gather information about the product, develop the formula, and our team of qualified technologists takes responsibility for it. Laboratory work is confirmed by the preparation of full documentation, preceding the necessary tests. We also assist in determining the classification of the medical product.

The next step is branding the medical product – with the help of our experts, we design packaging and labels in line with the composition, purpose, and client’s guidelines. After formulating the product, it goes to our modern production line, where it is manufactured in compliance with applicable laws. We then assist in preparing documentation and submitting the product to the necessary authorities. We support clients in distribution and preparing advertising strategies for medical products, positively impacting sales.


Benefits of Contract Manufacturing of Medical Products

  • Compliance with Regulations and Requirements

The production of medical products requires compliance with procedures during the production stage, as well as adherence to guidelines and legal regulations regarding product registration. For a cosmetic/pharmaceutical brand entering the market, this can be a significant challenge. A contract manufacturer is familiar with legal regulations, applying rigorous procedures developed through years of experience, relieving the commissioning entity of the need to carry out various activities or acquire knowledge. We, as Adex Cosmetics&Pharma, manage the entire process of producing medical products – from developing the formula to the final product and distribution.

  • Ensuring the Highest Quality of Medical Products

By meeting the highest quality standards, the client receives a fully valuable product. This is possible thanks to quality control, the assessment of all products, adherence to ISO norms, and legal regulations. Private label entities are responsible for quality control using advanced equipment. They also identify potential areas requiring improvement in the production process.

  • Supply Chain Management

A contract manufacturer organizes tasks holistically: procurement of raw materials, storage, production schedule management, engagement of technologists, laboratory technicians, and production workers. Private label entities can reduce costs at all stages of the process by negotiating lower rates with subcontractors, thus offering lower service prices.

  • Optimization of Company Costs

The absence of the need to invest in purchasing production lines, expanding the machine park, hiring employees, or lower costs of energy and supplies – these are the most important benefits provided by contract manufacturing. Thanks to this, pharmaceutical companies, medical entities, and individuals can realistically save tens of thousands of zlotys. The accumulated funds can be allocated to company development: marketing, employee training, expansion into other markets.

  • Comprehensive Service

From formulating the recipe, conducting tests, to the production of the product and registration with relevant authorities, including organizing distribution. The client gains a package of benefits.

  • Sharing Knowledge and Experience

Engaging firms in private label services allows for the use of their knowledge, know-how, and experience. We have executed hundreds of projects for medical entities, and our clients can benefit from our experience, gaining assurance of receiving the highest quality product.

  • Quick Entry into the Market

Contract manufacturing of medical products is an opportunity to increase the scale of business and enter the market more quickly. Well-prepared procedures, knowledge of regulations, and thorough preparation of documentation guarantee an efficient process of manufacturing products on demand, which may be shorter than production in one’s own facility. A precise agreement specifying the delivery time also protects the client from delays and downtime.

  • Expansion into Global Markets

Through knowledge, know-how, and contacts, a contract manufacturer can help pharmaceutical companies enter foreign markets. This opens up immense benefits for the entity in acquiring new customers on global markets. Through collaboration with various entities from multiple countries, the client gains invaluable support.