Discover our services
Drawing upon years of experience, our team has formulated a systematic approach supported by extensive knowledge of excipients, equipment, processes, and documentation. We excel not only in solid dosage forms like soft capsules and tablets but also in the development of advanced delivery systems tailored for oral, pulmonary, and local applications.
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With expert knowledge and hands-on approach, we drive the development of solid dosage forms from the target product profile until submission. Our core competence in the formulation and analytical development of tablets and soft capsules is supplemented by patent landscape evaluations, regulatory assessments tailored for the EU and US markets, on-site supervision during campaigns and management of involved third parties.
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We assist clients in identifying and evaluating potential CMOs, providing comprehensive benchmarking to ensure the right fit for their specific requirements. Our RFQ management expertise streamlines the supplier selection process, enabling efficient negotiations and optimal partnerships. Once the team is selected, we coordinate the involved parties and ensure efficient project structures and reporting.
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Leaning on a solid background in formulation and analytical development, we prepare development reports and relevant CTD Modules (e.g. 2.3 and 3) for IND/IMPD files or for final dossiers for registration.
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We support troubleshooting of soft capsules and solid dosage forms starting with a thorough document review and covering analytical and manufacturing aspects.
Here’s how it works
Discover our approach to formulation design, development, and manufacturing. From initial analysis to end product, we’ve got you covered.
1. Preliminary consultation
Initiate the process with an introductory meeting where we delve into understanding the current state of your project, your unique requirements, and the pivotal aspects involved. Regardless of your project's development stage, our team is equipped to offer valuable support at any phase.
2. Evaluation and analysis
Collaboratively, we formulate a comprehensive development plan tailored to your project. Whether you're embarking on a new development cycle or seeking enhancements for an existing product, we conduct a meticulous analysis to identify gaps and areas for improvement.
3. Implementation
Our consultative services extend throughout an extended cycle, ensuring continuous monitoring, guidance, and insights to enhance your understanding of the softgel product and its crucial components. This approach is designed to facilitate ongoing improvements and optimize the overall efficacy of your project.
What our customers are saying
"With solid expertise in soft gelatin capsule 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 the change of CMOs.”
CSO of a biotech start-up*
(personal reference upon request)
Past projects
Our portfolio of projects reflects our diverse pharmaceutical strengths.
*For the sake of privacy, all customers have been kept anonymous. Personal references are available upon request.
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The Client: A pharmaceutical company developing an NCE drug for world-wide rollout tasked us with the formulation lead role for the development of an extended-release tablet at a CMO.
The Challenge: The main challenge was to develop a formulation for a poorly soluble compound matching a specific extended-release profile.
The Solution: Applying DoE principles, we proposed the formulation, finetuned it to match the target dissolution characteristics and helped establish the final market formulation.
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The Client: An international leader in kidney and blood health who needed independent expertise.
The Challenge: The company needed to assess the decision on the development of an NCE in a liquid-filled hard capsule as a line extension to a soft capsule.
The Solution: upon consideration of technical feasibility, bioavailability, regulatory, and commercial aspects, we provided the basis for management´s decision on the program.
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The Client: A global innovator in oncology and cardiology needed support during the final phase of their product
The Challenge: Our client requested support during the final phase of launch preparation for a brand combination product of anticoagulants.
The Solution: By defining of appropriate processing conditions at a commercial scale, the robustness of the process could be increased significantly, ensuring bioequivalence and product stability regarding purity and dissolution.
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The Client: A combination product based on a resorbable carrier with a ready-to-use formulation of antibiotics was to be submitted to the US-FDA for chronic wound infections.
The Challenge: The sourcing of antibiotics, analytical method development, and regulatory strategy of this drug-device combination product were critical factors in this project.
The Solution: Tasked with CMC project management, we supported the program in defining the development program, coordinating involved parties, and drafting of CMC documentation for IND/NDA submission to the FDA.