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APL

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APL

APL is one of the leading contract manufacturers (CDMOs) in Scandinavia. With our 450 employees and four production plants, we have resources for developing, analyzing and manufacturing of pharmaceuticals. APL contributes to medical products that improve and save lives. APL facilities are fully cGMP compliant and are regularly inspected by EMA, FDA and customers corporate QA.

Preclinical development to commercial manufacturing

APL provide experience, expertise and services in product development of pharmaceutical drugs, supporting clients throughout the development process – from preclinical development to commercial manufacturing. Clients include companies in the pharmaceutical, biotech and medical technology branches of life science and range from international market leaders to medium and small start-up companies. APL’s broad experience and flexible resources can be tailored to suit every stage of the development process, as well as every size company.

Contract services

APL’s contract services range from formulation and analytical method development, development and manufacturing of clinical trials materials to commercial manufacturing of pharmaceuticals. APL manufactures pharmaceuticals in solid dosage form, as well as semi-solids and sterile pharmaceuticals such as injection solutions. APL also manufactures pre-filled syringes, vials, ampoules, portable cassettes and tailor-made packaging to facilitate home-based care. APL’s services and product package comprises all phases from pre-clinical testing to manufacturing of registered products.

Life science products with quality

APL strives to increase the quality of the client’s product lines at lower costs, thereby increasing the client’s competitive edge. High quality life science products have a great impact on the lives of a vast number of people, making patient safety one of APL’s most important cornerstones, alongside being a reliable, safe and cost sensitive partner for its clients.

Contact

Michael Brobjer, Marketing Director Head of Business development
Email: michael.brobjer@apl.se
Email: info@apl.se
Company website: www.apl.se
Phone: +46 10 447 96 00

Clinical Trials

Proper study planning requires more than just technical know-how. To define study objectives and to choose adequate parameters for measurements and evaluation, medical knowledge as well as biometric skills are essential.

Correct sample size calculation, a sound statistical analysis plan, and the development of well-structured CRFs also require input by seasoned experts. MEDIDATA offers expert services for all aspects of study planning and preparation. We outline study plans, develop study protocols and related documents (statistical analysis plans, CRF [both paper and EDC], patient information, etc.), manage…

Commercial Manufacturing

APL’s manufacturing services are suited for both commercial products and clinical trial materials. We offer contract manufacturing in cGMP grade facilities in most formulations, from aseptic (or sterile) injection solutions to capsules, suppositories, semi-solids, ointments and oral liquids. Companies choose APL as their contract manufacturer of pharmaceuticals for our flexibility and cost effectiveness; always trying to meet the customers needs.

During the development of manufacturing processes we focus on identification of critical process parameters to facilitate scale up and process validation. Scale up and validation of the manufacturing processes is performed in collaboration between the development and production team. APL support its customers by documentation of scale up and process validation in CTD format or…

Development and Manufacturing of Clinical Material

APL offers a complete development program with flexible resources. Our formulation scientists and analytical chemists are used to develop most types of dosage forms for clinical trials and commercial manufacturing. Our development services are carried out in close cooperation with our customers, with an experienced project leader as single point of contact and support until the project has achieved its objectives. We develop analytical methods and validate these according to ICH Guidelines.

The development is documented in technical reports or according to customers needs.
Quick Contact APL
Quick Contact APL


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Quick Contact APL


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