Business Areas
Lyomark Pharma is active as a service provider in four areas.
Lyomark Pharma organises the manufacturing of products on the basis of internally created and up-to-date dossiers.
Contract Manufacturing & Development
Lyomark Pharma has been working with reliable, internationally established contract manufacturers for many years. Lyomark Pharma continuously supports every product, from development, through authorisation and production, to the finished goods ready for sale.
All authorised manufacturers work with the most modern and innovative manufacturing technologies and according to GMP guidelines in manufacturing and quality assurance.
Lyomark Pharma regularly audits its suppliers to ensure consistently high product quality.
Thanks to the employees' many years of market knowledge and expertise in the field of contract manufacturing, you will receive tailor-made services for your product and your market.
We are organising the following services for you:
- Pharmaceutical formulation development
- Development from pilot scale to validated commercial batch size
- Manufacture and packaging of lyophilised products and injection solutions
Market Supply:
- Procurement of all active pharmaceutical ingredients and excipients and the qualification of the active pharmaceutical ingredient suppliers
- Pharmaceutical Analytics
- Development of packaging materials
- Storage and Logistics
Pharmaceutical Active Ingredients
Our competent team will support you with market analysis and in selecting the right supplier, offering you access to a comprehensive range of active pharmaceutical ingredients along with the associated documentation, such as CEP and EDMF.
Lyomark Pharma will, upon request, handle the complete logistics for the supply of auxiliary and active ingredients, store your goods according to GMP guidelines, and deliver on-time to the responsible production facility upon call-off.
Lyomark Pharma works with leading manufacturers in the development and marketing of active pharmaceutical ingredients.
Lyomark Pharma offers various regulatory services for clients in the pharmaceutical industry.
Regulatory Services
In addition to providing our product dossiers and the subsequent submission of authorisations, the following further services are also available:
Product Quality Review (PQR)
Lyomark Pharma offers the creation of the PQR, at the desired intervals if required. Alternatively, the raw data will also be provided for your own creation of the PQR.
Database query
Lyomark Pharma conducts regular queries of relevant databases at desired intervals.
Periodic Safety Update Report (PSUR)
Lyomark Pharma generates the PSUR at the desired intervals upon request and prepares it ready for submission. If desired, company-internal data will also be implemented.
Sales & Partnerships
In addition to direct sales in Germany, Lyomark Pharma also grants distribution licences to international distribution partners for the worldwide distribution of Lyomark Pharma products.
Furthermore, there is the possibility of a co-distribution arrangement for selected products in various countries. Lyomark Pharma is always exploring new ideas in this regard to further expand its global business.
Since 2007, Lyomark Pharma has been distributing its own products directly within the German hospital market and licensing to international distribution partners.