Discover our services
We provide comprehensive solutions throughout the entire development lifecycle, including sourcing strategy consultation, formulation development for your softgel capsule, and preparation of CMC documentation for registration. Whether you're at the initial stages, seeking registration advice, or troubleshooting an existing commercial product, we have got you covered.
Pharmaceutical development
We consider the critical aspects of the entire capsule from day one—starting with an initial assessment to the final concept.
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For new softgel developments, we create a target product profile, encompassing technical, regulatory, and marketing perspectives—ensuring compliance with ICH Q 8 standards.
The physico-chemical characteristics of the drug substance are scrutinized to determine the optimal softgel capsule formulation. A literature review, considering patents, similar products, and published papers, enhances our insights.
Our process includes an initial formulation and risk analysis, leading to a shortlist of capsule fill and shell concepts, accompanied by an ICH Q 8 compliant risk assessment.
We collaborate on designing a fill-and-shell screening program, refining it with the chosen CMO. Throughout development, we meticulously review documentation and monitor on-site campaigns, ensuring protocol adherence and data integrity.
Technical support
We support troubleshooting and setup of manufacturing capabilities by applying specialized knowledge of equipment, formulation, and analytical aspects
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We start by requesting documentation and assess the data with a focus on the issue. If more information is needed, we may perform a literature review comprising e.g. reference listed drugs, authority assessment reports, published data, patents, similar products, and publications. We may consult our network comprising raw material and equipment suppliers, analytical laboratories, or manufacturers.
We then prepare a report summarizing the reviewed data and our findings. It will include an action plan with recommendations for additional studies or immediate improvements.
We follow up on the action plan in regular meetings to assess new data and additional studies. The level of our involvement depends on the actions and can comprise elaboration of formulation screening programs, analytical troubleshooting, equipment selection, recommendation of partners, ongoing review of documentation, etc.
CMC documentation
We provide expert CMC documentation ready for submission to authorities and tailored for soft capsules. We know where to take your product.
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We use all raw data and intermediate reports provided by all partners to prepare comprehensive CTD module 2.3 and 3 documentation, including detailed development reports and stability assessments.
The devil is in the details: we know how to represent the product best and provide authorities with the information in the format and scope they expect to see.
Sourcing strategies
We leverage a reliable network of soft gel capsule experts to streamline your partner selection process.
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Leaning on a proven network of experts in soft gel capsules, we provide a shortlist of suitable partners and manage the RfI / RfPs.
Once the proposals are available, we prepare a report with benchmarks and recommendations for partners. A technical audit can be performed at the selected partners. We have established an extensive partner network for the development, manufacture, and analytical services of softgel capsules.
Applying CDMO insider knowledge, we help you find the right fit for the specific requirements and provide comprehensive benchmarking. Our RFQ management expertise streamlines the supplier selection process and enables efficient negotiations and optimal partnerships.
Here’s how it works
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Step 1: Introductory Consultation
We conduct an introductory meeting to understand the project status, your needs, and the critical factors. It doesn’t matter at what stage of the development cycle you are—our team can provide support at any phase.
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Step 2: Assessment and Gap Analysis
Together, we come up with a development plan for your softgel product. If you are in a new development cycle, we start with outlining the development of your softgel; if you already have a softgel product, we conduct a critical analysis for improvement.
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Step 3: Project Execution
Our consultatory services operate on a long-term cycle, which means we monitor, continuously provide guidance, and help you understand the softgel product and critical factors to make it better.
"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
We have worked on more than 50 projects at various points in their development cycle.
*For the sake of privacy, all customers have been kept anonymous. Personal references are available upon request.
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The Client: A mid-size international pharmaceutical company specializing in generic products.
The Challenge: The company faced various issues in their first development projects on a new softgel manufacturing line, including content uniformity and crosslinking of capsule shells leading to dissolution failure.
The Solution: With our support, the customer was able to identify and control better critical process parameters along with generating sufficient data for submission.
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The Client: A pharmaceutical start-up with documentation issues.
The Challenge: A formulation had to be developed for a poorly soluble drug substance. We were tasked with the definition of the development program for a Self-Microemulsifying Drug Delivery System (SMEDDS) formulation and coordination of the development activities with the CMO.
The Solution: Our team was instrumental in reviewing and ensuring the transparency of all development documentation, while the customer could concentrate on the clinical program of the drug.
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The Client: A mid-size pharmaceutical company with no previous experience in soft gels.
The Challenge: We were tasked to manage the entire development program for a generic soft gel product for the US market.
The Solution: We identified suitable partners for a generic development project. Our team managed the Chemistry, Manufacturing, and Control (CMC) aspects of the project from inception to submission. This strategic partnership enabled the client to successfully venture into soft gel development.
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The Client: A start-up company based outside of Europe developing a NCE product.
The Challenge: The supply chain of the product was highly fragmented. A suitable European CMO had to be identified for the Phase-III clinical supply.
The Solution: Our team took charge of the product implementation, ensuring a seamless transition to the chosen CMO. In addition, we drafted the relevant sections of the IND file in compliance with current regulatory requirements for soft gel capsules.
FAQs
What services do you offer?
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We provide end-to-end support across the softgel capsule development lifecycle. This includes pharmaceutical development, technical support, CMC documentation for regulatory submission, and sourcing strategy consultation. Whether you're starting a new formulation, preparing for registration, or troubleshooting a commercial product, we can support you.
At what stage of development can you get involved?
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At any stage. Our team supports projects from the earliest concept work through to commercial product troubleshooting. The introductory consultation helps us understand where you are and what you need.
How does the process of working with look like?
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There are three steps. First, an introductory consultation to understand your project status and needs. Second, an assessment and gap analysis where we build a development plan together, either outlining a new softgel or critically reviewing an existing one. Third, project execution, where we monitor progress and provide ongoing guidance.
What kind of technical support do you provide?
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We help with troubleshooting and setting up manufacturing capabilities, drawing on specialized knowledge of equipment, formulation, and analytical aspects.
Tell us about your project.
Our team of softgel capsule experts is standing by to help you on your journey.