Home » Commercial Services » Softgels Innovative Softgel Solutions Technologies for OTC and Rx products that maximize your market potential: where ideation and expertise come together. Rx and OTC Product Development Regulatory Services and Support Proprietary Softgel Technologies Hear from Our Softgel Experts Softgel Advantages Thermo Fisher Scientific’s Softgel Capabilities Decades of experience. Capabilities spanning development through commercialization. Our dedicated encapsulation facilities in High Point, NC, and Tilburg, Netherlands have the capacity to produce 10–12 billion softgels annually. Why do Softgels make sense for both Rx and OTC? Whether your product has solubility issues—like 70% of drugs in development—or requires abuse-deterrent technology, softgels may be the best formulation choice. With a lot of competition between CDMOs in both the United States and Europe, choosing the right partner to develop your Rx softgel drug can be a difficult decision. Thermo Fisher Scientific brings decades of experience from capabilities spanning development through commercialization. Our dedicated encapsulation facilities in High Point, NC, and Tilburg, the Netherlands have the capacity to produce 10–12 billion softgels annually. Our scientists are skilled in developing softgel formulations in early development to overcome bioavailability challenges and speeding new molecules to clinic. We also develop softgel formulations for late-stage lifecycle management, helping our clients retain market share and maximize product lifetime value. Our development and manufacturing capabilities include manufacture of highly potent drugs, DEA-controlled substances (Schedule I–V and List I) and abuse-deterrent products. And when existing Rx or OTC products need new revenue streams, product and brand managers can tap into our softgel expertise and proprietary technologies for new softgel product formulations. For product development we offer cost-effective and flexible business models ranging from fee for service, licensing of existing products and (co)-development of proof of concepts. We have the experience of formulation, analytical method and process development plus the manufacture of clinical material across all phases and scale up to commercial manufacture. For OTC products needing new life, Thermo Fisher can offer innovative ideas on brand expansions via our own softgel technologies to give your branded product a competitive advantage. We can also develop product proof of concepts to bring new products to market or allow you access to our own licensed products. We have established 180 patents (30 pending) associated with shell technologies, fill technologies and products. We have an experienced R&D team with expertise in early Rx development, generic and life cycle management development with low (<1 µg) and high dosed (1000 mg) active pharmaceutical ingredients ranging from high potent, hormones, scheduled drugs and a wide variety of indications (for example pain, oncology, women’s health, hormone regulation, allergy, cough cold). Partner with Thermo Fisher to realize the full potential of your product. As well as clinical development for Rx products, Thermo Fisher Softgel services bring value to pharmaceutical and consumer health care companies through ideation sessions and flexible business models that can: Develop product Proof of Concept to confirm market interest Provide innovation for product lifecycle management Provide solutions for Rx, OTC and tablet to softgel switches Enhance bioavailability to obtain quicker onset of action Provide formulation options for specific patient populations including pediatrics and geriatrics Discover the patient benefits of softgels and our diverse technologies that can meet the needs of your molecules and markets. Regulatory Services and Support Our regulatory affairs team in Tilburg provides unmatched support for clients during development/pre-approval and post-approval for dossier maintenance. Our experience with various regulatory bodies and close relationship with your drug’s development team, make us easy to work with and can help you get to market quickly. Experience in regulatory affairs and procedures, with the ability to provide independent and optimal advice on the best regulatory strategy on a case-by-case basis Submission of the applications (as eCTD) to regulatory authorities, subsequent monitoring of the procedure, responding to regulatory queries and the formal closing of the application procedure Our offerings throughout development and pre-approval include: Support during product development following ICH, EMA and FDA regulatory guidance Regulatory dossier compilation of Module 3 in compliance to current guidelines (writing and collecting documentation needed for the submission) Guidance during the clinical study: e.g., selection of reference product, preparation of IND, IMPD and clinical trial applications. Clinical Trial labelling, packaging and distribution (via Thermo Fisher clinical services) Guidance throughout the clinical and bioequivalence study process Our regulatory affairs assistance does not end at drug approval. We offer post-approval compliance review of dossiers according to ICH, EMA and FDA legislation, as well as maintenance throughout the dossier lifecycle, such as variations and renewal applications submitted to the competent authorities. To learn more about how our team can make your submission a success, please contact our experts here. Back to Top Thermo Fisher’s Proprietary Softgel Technologies Chewels® chewable gels are approved for pharmaceutical use and are ideal for pediatric and geriatric populations. They are also well suited for people who find swallowing difficult and are looking for a convenient dosage form for administration. Our EnteriCare® technology incorporates the enteric properties directly into the gelatin shell, replacing extra steps such as coating during the manufacturing process. This creates more consistent enteric behavior. EnteriCare products can be developed as transparent softgels, which creates a more appealing aesthetic quality compared to traditionally coated capsules. Previous Next Back to Top Hear from Our Softgel Experts Have a question about softgels? Ask our Softgel Experts. Back to Top Softgel Advantages Faster release and onset of action Easier to swallow Better effectiveness, with targeted delivery No bitter taste or odors Innovative solutions for specific populations (e.g. pediatric) Numerous options for shape, size and color Suitable for pediatric and geriatric markets Product life cycle management and brand sustainability Portfolio differentiation, solid dose to softgel and Rx to OTC switches Ability to enhance bioavailability Better control of drug release Better ability to target absorption location Better stability for APIs that are prone to oxidation or degradation Better containment of potent compounds Ability to deliver low-dose APIs Simple scale-up. Commercial batches can run on the same equipment as clinical batch quantities. Back to Top Download our Softgel Technologies Overview brochure to learn more about the benefits of our proprietary technologies. Download Brochure Related Sites Bend, OR Brisbane, AU Previous Next Additional Resources Previous Next © 2021 Thermo Fisher Scientific Inc. All rights reserved. Cookie UsePrivacyTerms Of UseModern Slavery Statement