Innovative services for product development, sourcing and delivery

Azelis Pharmaceuticals offers exceptional support to pharmaceutical, veterinary and health care companies. Our level of market knowledge combined with added value services, superior manufacturer relationships and integrated supply chain enable us to enhance client product offerings and optimise competitive solutions.

Our exceptional support services include:

Quality Control and Quality Systems

Pharmacists and chemists with a team of laboratory assistants supported by a (AMG) Qualified Person ensure the quality of all the substances we sell.

Azelis provides total visibility of manufacturing source and encourages customer audit trails of manufacturing, storage and supply routes. All products are supported by valid efficacy data. We offer established lot traceability on all of our products and original manufacturers documentation on each product, including specification, MSDS, C of A and other appropriate standards.

Our regularly audited facilities are compliant to the highest local quality systems in each country we operate in. Our manufacturing authorisation, including GMP certificate, is approved by both the  Bezirksregierung Düsseldorf and MHRA for storage and distribution of psychotropic drugs and controlled substances.

As a Responsible Care® company, we work to continually improve our operational standards with respect to health, safety and the environment. Furthermore, we are very active with REACH compliance.

Supply Chain

We have hub warehousing, supported by fully integrated business management systems, enabling us to provide fast professional handling and delivery of ingredients to your manufacturing facilities, as and when you need it.

Specific capabilities for pharmaceutical warehousing include:

  • Narcotic drugs
    We have diverse narcotic licenses and have specially-secured stores for narcotics.

  • Temperature-controlled storage
    Besides air-conditioned warehousing, which ensures a controlled temperature for our active ingredients and auxiliary materials of under 25°C, we also have a cold store that enables conditioned storage at < 7°C.

  • Filling/Repacking/Labelling
    We refill active ingredients under cGMP conditions and excipients under FDA-certified clean-room conditions.

Applications Laboratories

Our laboratories offer quality control for own brand products and can be used for testing and developing ingredients at the micro-level. Demonstration concepts can be provided for all topical healthcare applications.

Typical applications work includes:

  • Confidential supplier and customer specific projects
  • Stability testing • Microbiology
  • Pilot runs for customers (using our 3kg vacuum reactor)
  • Microscopic analysis
  • Product approvals
  • Regulatory testing

Expert Advice

We have experienced pharmaceutical formulators who can help you to explore new ingredients and different combinations under strict laboratory conditions.

With over 65 dedicated pharmaceutical experts covering everything from product development to sales channels and logistics, you can rely on us for insightful advice, helping you meet your product and commercial objectives.

We can help you to find the right substance from a choice of worldwide suppliers who manufacture to the highest quality standards, and supply products with complete documentation and transparent supply-chain information.

Flavour Technologists

Our flavour technologists understand how to bring key differentiation elements in profile –masking of bitter taste and hot and cold sensations without the overpowering heat of capsicum or bitterness of menthol – all suitable for use in pharma applications.

Regulatory Affairs

We have an experienced regulatory affairs team who can help you with:

  • Registrations and registration dossiers
  • Reformatting of older registration dossiers into current Common Technical Document format (CTD)
  • Own and third party Certificates ofm European Pharmacopoeia (CEPs)
  • Evaluation and registration of Active Substance Master Files (ASMFs)
  • Assistance for GMP upgrades
  • Rationalisation of customers’ audits

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