Development Services

A key part of a drug development process is the thorough characterization of the active pharmaceutical ingredients (APIs).

The testing of raw materials used in the drug product or delivery device development and manufacture is important to ensure that they are suitable for their intended use and to prevent production delays and problems.

Formulation development includes a careful selection of all needed APIs and excipients as well as a deep understanding of how they interact with each other. This is of particular importance for complex dosage forms such as Dry Powder Inhalers. Our experts help support the relevant early formulation steps and the associated characterization.

Drug delivery device development involves multiple steps, including concept research, device design, prototyping and scale up.. We can help you test and qualify device concepts by developing relevant prototypes and functional models and pilot devices to help transform innovative ideas into commercial success.

Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. They require a careful evaluation which considers the presence of both a drug part and a device part.

We apply engineering simulations throughout development of new solutions that can help bring new treatments to patients, while meeting safety standards and product deadlines.

We offer turnkey solutions for ready-to-use products including assembly, filling, and packaging support.

Technology transfer is the process by which the manufacturing process and analytical methods are transferred from one manufacturing unit to another unit or from R&D to the manufacturing unit.

Stability studies are a time consuming and resource intensive task in the development of new drugs. Therefore products are tested under accelerated conditions to increase the rate of chemical and/or physical degradation.

Human factor studies try to eliminate or reduce the impact of errors related to the use of a drug product, in particular when there is a device part of this product. These are an integral part of any drug product regulatory submission.

We can help you develop a winning strategy for your generic drug to achieve market share, growth and sustainable value.

QbD is a systematic approach to product development that starts with predefined objectives and emphasizes product and process understanding and process control, based on science and quality risk management.

The Chemistry, Manufacturing and Controls (CMC) is part of a pharmaceutical clinical trial or marketing application. It ensures that the product is safe, effective and consistent between batches.