HELPING YOU SOLVE YOUR CHALLENGES
Partner with Bioglan for Your Development and Manufacturing Needs Bioglan, founded in 1984 in Malmö southern Sweden, is a trusted Contract Development & Manufacturing Organisation (CDMO) specializing in semi- solids for pharmaceutical, med tech, and cosmetic companies. Bioglan has been part of the Spanish Reig Jofré Group since 2009. With over 40 years of experience, we offer comprehensive services from development to commercial manufacturing, ensuring quick turnaround times and high- quality results and products. We are EU GMP approved and hold ISO 13485 certification, demonstrating our commitment to the highest standards of quality and regulatory compliance. This dedication ensures dependable and reliable results for our clients. Bioglan undergoes approximately ten customer audits annually, reenforcing our adherence to both regulatory standards and industry best practices. At Bioglan, we are dedicated to helping you solve your challenges!
Sustainability Sustainability ensures long-term viability, reduces environmental impact, and meets the growing demand for eco-friendly practices in the pharmaceutical, med tech, and cosmetics industries. Bioglan has a strictly controlled environmental monitoring system and holds ISO 14001 certification, covering the entire company, including the full supply chain. This reflects our commitment to environmental sustainability and responsible business practices. We use 100% renewable energy for our electricity needs. By integrating sustainable practices, Bioglan not only minimizes its carbon footprint but also aligns with the values of customers and consumers who prioritize environmental responsibility and growth.
Development services Our team of experienced scientists and dedicated project managers are here to support and guide you through the development of semi-solids such as creams, gels, ointments, and lotions. With a wide range of on-site manufacturing capabilities, from small lab scale to commercial batch scale, we ensure that our formulations and processes are easily transferable to large-scale manufacturing. Our formulation development services are dedicated to creating effective and patient-friendly dosage forms. We focus on designing dosage forms specifically tailored to the target condition for optimal therapeutic effect. This includes selecting non-sensitizing excipients with low irritation potential and conducting comprehensive stability testing to ensure long-term product integrity. This approach ensures that the final formulation is stable, user-friendly, and effectively delivers the active ingredient, with thoughtful consideration of the need for stabilizers or preservatives. Bioglan Services
Clinical and Preclinical Trial Services Bioglan offers comprehensive clinical and preclinical services, supporting your clinical development from early-stage trials through to pivotal studies. With experience in producing clinical trial materials, our dedicated pilot plant is equipped to produce small-scale batches for initial trials, while our main facility manages commercial-scale batches needed for later phases. We also manage packaging and labelling according to randomization lists. Analytical services We offer high-quality analytical method development services tailored to your specific project needs. Our skilled and experienced team provides comprehensive support, from developing and validating robust analytical methods to routine quality control testing. Our state-of-the-art laboratory and extensive network of partners enable us to handle all analytical demands throughout the product life cycle. Our services ensure that your product consistently meets all required specifications, from raw materials to finished goods.
Contract Manufacturing – Specialized in Semi-Solids With 40 years of industry expertise, Bioglan stands out as a committed CMO and full-service provider dedicated to addressing all your needs. We prioritize mutual growth with our partners, continually investing in our facilities, staff, and quality systems to stay ahead of evolving demands. We closely monitor the entire supply chain—from the initial order to the final shipment—ensuring exceptional service and precise delivery while upholding the highest standards at every stage of the process. We focus on building long lasting partnerships based on trust and clear communication, recognizing the crucial role we play in your supply chain.
Tech transfer service Our experienced project managers are here to support you throughout the tech transfer process with their deep understanding of commercial manufacturing. We use a risk-based approach and established practices to ensure a smooth transition. With transparent communication and regular updates, you will stay informed and involved in every step of the project. Life cycle management We provide comprehensive life cycle management services to support your product post-approval. This includes managing necessary changes, continuously optimizing the product to maintain competitiveness, and ensuring compliance with evolving regulations. Our close partnership with customers involves proactive communication on product improvements, timely updates on changes to maintain the product dossier, and leveraging annual Product Quality Reviews (PQR) for ongoing enhancement. Additionally, we offer support in risk assessments and safety data exchange to ensure your product remains compliant and competitive throughout its life cycle. Many of our customers have been with us for decades, from initial idea to commercialization and market growth.
Mailing address Bioglan AB PO Box 50310 SE-202 13 Malmö Sweden Visiting address Borrgatan 31 Malmö, Sweden +46 (0)40 28 75 00 info@bioglan.se bioglan.se Bioglan
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