Unlock the science of softgel capsules

Your soft capsule development, amplified by our independent expertise.

We are experts in the development of soft capsules.

Backed by more than 30 years of experience, we use a systematic approach to understand your softgel product better. Our approach focuses on the critical aspects of softgel development to help you produce robust soft capsules.

Schedule a call with us and find out how we can support your softgel development project.

The challenge

Outsourcing softgel capsule development often brings confusion and a lack of insight into the process.

Our solution

With our background in prominent pharmaceutical CDMOs, we bring transparency and expertise to navigate the complexities of your soft gel development.

Why work with us 

Despite a century of industrial production, softgel capsules remain poorly understood. Each formulation presents unique challenges, demanding expertise in excipients, processes, analysis, and regulations for success. Bringing together the best practices in soft gel development, we stand as independent experts with real solutions.

Mitigate development risks

Avoid risks in the development process. We consider critical aspects for the entire capsule from day one following our structured, risk-based approach tailored for soft gel capsules.

Become the expert for your soft gel product

We support you in finding the critical factors for your softgel product and ensure complete development documentation. With our expertise, our team is there to empower your product.

Prepare state-of-the-art CMC documentation

Uncertain about regulatory expectations, or which agencies to see? We enhance your soft gel CMC documentation and prepare CMC sections for your IND/IMPD file in CTD format.

Get the right partners on board

Optimize your sourcing strategy and lead efficient negotiations with our extensive partner database for the development and analytical services of soft gel capsules.

Who we are

We are a team of pharmaceutical scientists with more than 30 years of experience in the CDMO space, bridging all crucial aspects for successful softgel development. Over the years, we've assisted numerous customers in developing, manufacturing, and bringing soft gel products to market in the EU and USA. Our portfolio encompasses over 50 softgel capsule projects.

From our Expert Resources Section

Resources
Latest updates to USP <1094>: key insights for softgel capsules
Latest updates to USP <1094>: key insights for softgel capsules

The United States Pharmacopeia (USP) recently updated Chapter 1094 (Capsules dissolution and related quality attributes), focusing on capsules' dissolution and related quality attributes. This updated version, effective from December 1st, 2023, introduces significant changes. What does that mean for soft gel capsules?

In this article, we summarize and discuss the main changes relating to softgel capsules.

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Selecting a CDMO for your softgel development
Selecting a CDMO for your softgel development

As niche dosage forms, softgel capsules require extensive expertise for successful development. Partnering with the right contract development and manufacturing organisation (CDMO) is essential to avoid inefficiencies, increased development costs, and protracted timelines.

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Shell formulation development for soft capsules
Shell formulation development for soft capsules

The shell of a soft gelatin capsule consists of the gelling agent gelatin, a plasticizer, water and optionally colorants. Compared to hard capsules, the soft capsule shell requires a higher amount of plasticizers and typically also has a higher water content.

While the shell of soft gelatin capsules is often simplistically regarded as mere packaging material for the capsule content, it can have a significant impact on the product stability and compatibility. A thorough approach to the shell development is therefore crucial. This article gives an overview on raw material selection, critical aspects and common quality issues during capsule shell development.

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Why people work with us

  • "With solid expertise in soft gelatin capsules development and a vast network in the pharmaceutical industry, the team supported us in matters of development, manufacture and regulatory writing. We were able to optimize our sourcing strategy and ensure continuity during change of CMOs. ”

    CSO of a biotech start-up*

    (personal reference upon request)

  • " Since we started consulting with the team 3 years ago, their vast experience in all areas of soft gelatin capsules CMC was clear in every conversation. They displayed a profound commitment to professionalism and this collaboration has greatly contributed to the smooth implementation of this technology in our company."

    R&D Head of an international pharmaceutical company*

    *personal reference upon request

Read more about our past projects

Now is the time to advance your soft capsule project.

Schedule a call with us and learn how we can help.