Excited to share feedback from a big Pharma client upon completion of analytical assignments!
“I want to thank you for everything you have helped us in different capacities. There are many things that you have been a great example for. Some of these are your ability to see the big picture and yet, treat every data set with utmost care and respect, your ability to see issues and risks and not be afraid to present these based on sound scientific reasoning. Without your critical thinking, broad view and support, we would not be where we are on the analytical sections!"
The assignments included analytical gap assessments, authoring and review of 3.2.S and 3.2.P sections for NDA/MAA submission of an oral dosage form indicated for blood disorders.
Can we help you with your needs in analytical and CMC development, authoring and review of CTD sections and CRO/CDMO management?
Visit us at: https://lnkd.in/d77JKuFf
A few specific examples of where DAT Pharma can help you include:
•Lead analytical program, e.g., design analytical plan, review experimental design, protocols, results, troubleshooting, and reports
•Impurities ID and controls for raw materials and finished products
•Manufacturing: order of addition, analytical controls, technology transfer
•Program management including selection and management of CROs/CDMOs
•CMC: strategies, starting materials, write and review 3.2.S and 3.2.P sections for IND, IMPD NDA, MAA, 505(b)(2), ANDA, and PAS submissions, Help in responding to complete response letters
•Veeva-Vault document management system: CTD content creation & reviews
•Establish reference standard program (characterization, method validations, and qualification) including review of experimental design, protocols, results, and reports
•Stability studies: Strategies and design
•E&L method development and validations
•Establish or remediate cleaning validations
•Remediate analytical validation, compendial compliance, and transfer work
•Help develop batch records and analytical controls for raw materials (drug substance and excipients) and drug products at in-process, release, and stability testing
•Help in root-cause analysis of CAPA, OOS, and FAR
•Write and review SOPs
•….
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Senior Director of Business Development, ex-formulator), LION over 14,000+ connections
3moI have enjoyed working with your team supporting the GMP and development formdev and clinical manufacturing support for the final dosage form.