Research and Development
Collaboration is in our DNA
Lelypharma assists you in the development of new products. We ensure that your ideas become medications that can be registered and produced. Each new product is developed according to a comprehensive research process and is made ready for registration and production in close consultation with the customer.
The introduction of a new product or process in our facilities always takes place on the basis of project management. Experienced experts in the field of pharmaceutical production, quality control and/or quality assurance, including our industry pharmacists, oversee any introduction.
You want to expand your market and are considering introducing your products in more European countries? New registrations require a lot of knowledge of local laws and regulations. Lelypharma will gladly share its knowledge with you and will assist you with the studies necessary to have your product recognised.
Lelypharma supports you with the structure of the documentation. We research the stability of the product under different climatic conditions and can advise you on how to increase shelf life.
Quality
Listening is just as important
Quality is of paramount importance to Lelypharma. All of our production and laboratory activities take place according to the European Standards for Good Manufacturing Practice. But Lelypharma goes beyond that. To us, quality also means: listening carefully to your special requirements. A product that meets the standard requirements is – if it’s good – available anywhere. But a product with better properties when it comes to shelf life, breakability or taste will give you an edge over your competition. Lelypharma wants to offer a level of quality that sets you apart from others.
Quality control
For all products, quality control is carried out internally by our well-equipped chemical and physics laboratory. In addition to regular quality control we can also carry out and implement validation studies and stability studies under different conditions.
In three steps
1. Quality control starts with research on the raw materials we use in accordance with current pharmacopoeia. This relates to both the active substances and the excipients.
2. Then, for the purpose of good manufacturing practices, we record each step in the validated production process of a drug in a formalised protocol. Internally, we verify that the procedures are followed properly.
3. The third step in the quality assurance process is the analysis of the end products using validated analytical methods, carried out using qualified equipment.
11 qualified people carry out the work in the Lelypharma laboratory. They have all received extensive laboratory training. Most of them have an analytical-chemical background. The majority have enjoyed higher education.
The Dutch standard
Medical products from the Netherlands are highly regarded worldwide. They contain the exact amount of required active substances. Shelf life as well as other specifications are all in order. Here at Lelypharma we keep this Dutch standard high through meticulous checks.
Inspection of raw materials
We take samples of all our resources and analyse whether they are pure and contain the required amount of active substances. We give the test results to our qualified person. He approves the raw materials for production.
Product testing
The production protocol describes all the critical steps in the manufacturing process of a drug. This is a ‘sacred’ document to us. Testing drugs forms an important part of the protocol.
We test every single drug we manufacture. The test results are recorded in a certificate of analysis. The qualified person assesses whether the analysis has been carried out properly and whether the product is meets our standards.
For the registrations, we examine the reliability of methods and processes and carry out stability studies: how well does the drug last over the course of time and under specific circumstances such as heat, light and moisture.
My LelyPharma
Access to your certificates and analyses anywhere, anytime. Being able to produce without delays, so doctors continue to prescribe your products? My Lelypharma provides you with immediate insight into the studies, the results and documentation:
- certificates of analysis
- certificates of raw materials
- certificates of quality
- BSE-free certificate
- reports with analysis and validation protocols
Regulations regarding medications require extensive documentation and certificates. Lelypharma assists you with the studies necessary for the registration of your products. At Lelypharma you will get exclusive and secure access to the documentation and certificates of your products. You have a complete and clear overview of all your projects at all times. With My Lelypharma, every customer has their own exclusive online domain.
My Lelypharma provides immediate insight into the results of studies and documentation of products.
You can view these in your own secure section. Exceptionally useful if you have international registrations in many different countries. You can find the overview here.
