Quality
We have a strong track record of quality performance. We routinely work with our partners to achieve improved quality of program candidates. Quality compliance is top performance attribute that we actively invest in and are constantly reviewing and improving. We have been successfully audited by authorities from around the world including Europe, Sweden, FDA and Japan amongst others.
GMP Compliance
Our vertically-integrated supply chain model provides development & manufacturing expertise spanning the complete cGMP supply chain from regulated raw materials through intermediates, APIs, commercial-scale drug substance manufacturing, niched formulation, clinical trial manufacturing and fill and finish, and supply chain logistics.
Quality Culture
Quality iis part of our values and we aim to assure rather than control compliance with regulatory requirements. By having a quality based culture there are fewer manufacturing issues and thus reduced downtime and product losses. Over 70 years of combined experience and successful audits and customer delivery along with an excellent quality reputation is a key to our history of winning.
Material Sourcing
If managed improperly, sourcing can result in supply chain interruptions, significant unexpected expenses and quality control issues. Our team of highly qualified sourcing experts ensure effective sourcing and building in supply safety, legal and regulatory compliance, and protecting timeliness of receiving materials to keep your project moving.
Regulatory Filing
Preparing for and working with the FDA, EMA and other world regulatory bodies requires a large amount of work. Insufficient documentation delays regulatory submissions can hinder bringing a new drug to market. We build regulatory requirements into every single project, from the first day forward. Using our experience in multiple successful filings we actively support regulatory drafting all through your project.
Talk to our quality team leader
Malin Melander
Malin holds a Master of Science in Engineering Physics from Lund University.She has 20 years’ experience from different positions within the healthcare industry, and joined Magle Chemoswed in 2018, reinforcing the quality and regulatory expertise within the company.
