Pharma & Medical
In the pharmaceutical and medical technology sectors, every detail counts – from the purity of an active ingredient to comprehensive supply chain documentation. Increasing regulatory requirements, growing cost pressures in healthcare systems worldwide and the need for resilient supply chains that are less dependent on individual regions have been shaping the sector for years. Biesterfeld supplies pharmaceutical manufacturers, generics producers, CDMOs and medical device manufacturers in accordance with the strict quality standards demanded by this sector.
Our strengths
Regulatory Expertise
As your regulatory partner, we guide you through the entire compliance process. We advise you on regulatory MDR and PMCF requirements, develop and manage quality agreements, and provide support with risk and change management.
Global Sourcing and Local Support
For global procurement, we connect qualified Asian manufacturers with regulated European markets. And with internationally oriented teams in the regions, we offer on-site support – in Europe, Asia and North America.
Joint product development
From technical problem-solving through to laboratory testing and validation, right through to material selection and production: our engineers work with you to develop your products and solutions.
Our portfolio
Our portfolio comprises active pharmaceutical ingredients (APIs) for human and veterinary medicine, pharmaceutical intermediates from chemical synthesis – including those for flavourings and fragrances – as well as raw materials for common dosage forms: oral medicines in solid and liquid form, suppositories, topical preparations and injectables. In addition, we supply manufacturers of medical polymer products: surgical and dental instruments, drug delivery systems such as auto-injectors, inhalers, insulin pens and pre-filled syringe components, wound care products, portable medical devices (wearables, such as those for continuous glucose monitoring) and tubing and catheter systems.
We also supply materials for pharmaceutical packaging, bioprocessing tubing, as well as animal health and pet care products. We operate in accordance with GMP and GDP standards, ensure full traceability through certified, audited storage facilities, and provide support with regulatory requirements – from technical documentation and stability data through to regulatory compliance support. Value-added services such as repackaging, blending and mixing under controlled conditions round off our offering and help to streamline our customers’ processes.
We provide comprehensive certificates of analysis, DMF and CEP references, as well as support with audits and supplier qualifications. Our GDP-certified warehouses enable temperature-controlled storage and distribution, whilst our regulatory team is on hand to assist with any queries regarding dossier preparation and authorisation documentation.
As a distribution partner with expertise in speciality chemicals, plastics and rubber, we do not see ourselves merely as a supplier, but as an extension of our customers’ production lines – from active ingredients and intermediates, through polymer components for medical devices, to rubber and silicone systems for hoses and seals. Global sourcing, local regulatory expertise and a network of vetted, authorised suppliers ensure security of supply, even for critical active ingredients and during supply bottlenecks, such as those this industry has repeatedly experienced in recent years.