Topical Product Development and Phase I and II Clinical Manufacturing

As a recognized world leader in the provision of pharmaceutical testing, Element provides specialist topical drug development and clinical manufacturing services to help you formulate safe, quality, and robust topical dosage forms.

The development of topical formulations poses unique challenges and issues to the pharmaceutical industry. Topical products must be physically and chemically stable, and allow for optimal penetration into the skin, in addition to being aesthetically pleasing.

Element has a well-equipped product development and testing facility and highly-qualified technical specialists with the expertise to help you develop your topical preparation in the preferred dosage form, including gel, cream, lotion, ointment, suppository, and emulsion.

Our topical drug development and clinical manufacturing services include:

• Pre-formulation and formulation development
• Analytical and microbiological development
• Process development
• Lab-scale and clinical batch manufacture
• Container/closure compatibility and integrity testing
• Batch release and stability testing
• Packaging and labeling
• Technology transfer
• Development of technical and regulatory documentation

Working with Element

With a clear understanding of topical product development, regulations and challenges, our scientists support customers from large multinationals through to virtual start-up organizations. 

We work closely with you throughout the entire product development process, from pre-formulation and formulation development to dosage form, skin penetration goals, packaging, labeling, and target shelf life, to ensure the success of your product.

To learn more about our topical drug development and clinical manufacturing services, or to speak with one of our experts, contact us today.