https://www.cmcdp.dk/knowledge-sharing daily 0.75 2025-12-08 https://www.cmcdp.dk/knowledge-sharing/cqa-based-impact-assessment monthly 0.5 2023-02-01 https://www.cmcdp.dk/knowledge-sharing/criticalqualityattributes monthly 0.5 2022-11-10 https://www.cmcdp.dk/knowledge-sharing/qtpp monthly 0.5 2025-12-08 https://www.cmcdp.dk/knowledge-sharing/leachables monthly 0.5 2022-05-25 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1630405733790-B0UGJ2Z0DAL38R2VUJWN/PQRI+triangle.png Knowledge Sharing - 3.2.S.6 & 3.2.P.2.4: Extractables & Leachables - Make it stand out The 3-step approach suggested by PQRI to analyzing leachables. https://www.cmcdp.dk/knowledge-sharing/32p25-microbial-attributes monthly 0.5 2021-10-04 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1629194266562-9K15Z26KAHG7C8E78N14/visual_no+color+bubbles.png Knowledge Sharing - 3.2.P.2.5 Microbial Attributes - Make it stand out Attributes that need to be controlled in order to ensure drug product sterility. For each variable a validation study or monitoring with well defined acceptance criteria should be in place. https://www.cmcdp.dk/knowledge-sharing/qbd-non-scalable-parameters monthly 0.5 2021-07-07 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1625637704481-4949OMPB8FU66AST9BTJ/non+scalable+parameter+justification+blog+post.png Knowledge Sharing - Non-Scalable Parameter Justification - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://www.cmcdp.dk/knowledge-sharing/biosimilar-formulation monthly 0.5 2021-07-01 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1625137916123-T1UND2S1TOJQGLH2CZYU/Biosimilar+decision+tree.png Knowledge Sharing - Biosimilar Formulation Strategy - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://www.cmcdp.dk/knowledge-sharing/blog-post-title-two-5hd5a monthly 0.5 2021-07-03 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1625131496210-3ZSZCIQPUGWHREO5OH6C/Process.PNG Knowledge Sharing - Specifications for Product Related Impurity Levels - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://www.cmcdp.dk/knowledge-sharing/tag/risk+assessment monthly 0.5 https://www.cmcdp.dk/knowledge-sharing/tag/critical+quality+attributes monthly 0.5 https://www.cmcdp.dk/knowledge-sharing/tag/quality+by+design monthly 0.5 https://www.cmcdp.dk/home daily 1.0 2025-10-16 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1610958971892-X9F5QDG0HQPQ2MS9SXEU/TANK_STOR_MARGIN.jpg https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1610958952220-Z2ZSUH407E88X12N8EMZ/DOCU_STOR_MARGIN.jpg https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1610963744117-O0D9W0O1A5OGEZXXB0VE/GRAF_STOR_MARGIN.jpg https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1610958994138-V385BM600GNZUP1RAZDI/VIAL_STOR_MARGIN.jpg https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/85d442c5-d00a-448d-a0d3-501de66f252d/AY3.jpg https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1634534324683-W9HAVANTVYAE150M6GWI/M.jpg https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/3dd73258-471d-440d-b58c-39fceb42d5c5/Toke_J.jpg https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1634534498986-NSUQB7TWKKJHPDOIGA9D/F.jpg https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1634534743793-0GEPMUJH3CXYDNV51F9H/S.jpg https://www.cmcdp.dk/drug-product-development daily 0.75 2023-12-07 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1610631486290-AKTJL4VCY9M6B7VCL50A/botox-close-up-injection-415816.jpg Drug Product Development - Our Service Avoid running into unwarranted delays and quality issues by collaborating with experienced professionals with a proven track record. We help you navigate the complexities of peptide and protein drug product development and make sure that your injectable drug product is robust and suited for the relevant clinical stage. All aspects of formulation and process development can be supported from first human dose to commercial launch including technology transfer and CDMO management. We also offer contract laboratory services through our sister company Formula One which is a fully integrated formulation development organization specializing in peptide and protein therapeutics. Examples on development activities supported: Drug product development strategy from early to late phase development. Experience in both new biological entities and biosimilars. Drug product development planning. Defining key CMC project tasks and best timing of activities in line with project milestones. Formulation screening for lead selection for first human trial. Formulation robustness assessment prior to commercial submission. Design of drug product stability studies to support shelf life and in-use claims including statistical data analysis. Process design and control strategy for drug product manufacturing relating to injectable proteins and peptides. Tech transfer of drug product process from lab scale to GMP facility for clinical trial batch production. Biosimilar formulation strategy and comparability evaluation Design of comparability protocols to support process and product changes Coordination of experiments at CDMOs including collection, review and reporting of data to facilitate decision-making. Once your drug product is ready for clinical testing or commercial launch we can help with the regulatory CMC writing of the dossier. For more information on our regulatory services click here. https://www.cmcdp.dk/qbd-for-biotech daily 0.75 2021-07-12 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1610632505656-S3YK1UIANXWLLDCAUTGQ/fabio-633881-box%2Bshapes.jpg QbD for Biotech Supported QbD elements Defining (Quality) Target Product Profile (Q)TPP Defining critical quality attributes (CQAs) Process risk assessment Drug product risk assessment Process design and control strategy DoE and Statistical data analysis https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1610632483792-VVMB6IEA41OEJV56C00I/architecture-building-business-256381.jpg QbD for Biotech - Our QbD Platform Tailored integration of QbD to meet your company needs. We create a QbD platform to support your development efforts which is fit for purpose with respect to your company size and structure and in line with ICH expectations. https://www.cmcdp.dk/data-analysis daily 0.75 2021-01-19 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1610633702056-LVQBPN21ODL0P3VRI1AS/neural%2Bnetwork.jpg Data Analysis - Our service Trust us with your data and we will extract valuable information to enhance your product and process understanding. Data Driven Problem Solving If you have a technical challenge and some related data we can assist you in performing data driven problem solving. Anything from a simple case to more advanced systematic problem solving can be supported. Predictive Statistical Modelling We offer advanced statistical data analysis to leverage and progress your development activities. All relevant drug product data can be handled such as unstructured product data, batch and stability data. We will enable you to make the best decisions to drive your projects forward. https://www.cmcdp.dk/cmc-strategy-and-advise daily 0.75 2021-06-29 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1610633980619-2EN0V97L9ME80LC0P4MZ/business-camera-coffee-1509428.jpg CMC Regulatory Writing & Advise https://www.cmcdp.dk/contact-us daily 0.75 2022-11-09 https://www.cmcdp.dk/privacy-policy daily 0.75 2021-05-04 https://www.cmcdp.dk/consultation-on-cmc-strategy daily 0.75 2025-10-16 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/1624533318074-HF2Q8QOKTSK8MI3EIO5L/4.jpeg Consultation on CMC Strategy - Make it stand out My name is Faramarz and I have more than 16 years experience working with CMC development in large pharmaceutical companies. I know the process of taking new biological entities or biosimilars through CMC development up to commercial submission. https://www.cmcdp.dk/formula1 daily 0.75 2025-10-16 https://images.squarespace-cdn.com/content/v1/5feb51a6dcfe2f065c91b026/0450464c-1e48-4fcd-b812-a0a794353076/Vial+with+logo.png Formula Lab - Formulation Development Formula Lab is our contract laboratory organization specializing in formulation development of injectable peptides and proteins for clinical use. This is your one stop shop for CMC drug product consulting and formulation development. Click on the link below to learn more.