Work from our office or on site
Experience with injectable solutions and suspensions and aseptic manufacturing
Data trending, review and CMC writing. Multiple NDA's submitted as eCTD's.
Work from our office or on site
Services
Product Development
Capable of managing all elements of product development from sourcing raw materials for drug substance manufacture to validation of commercial processes for drug product manufacture. Experienced in managing multi-national supply chains and multi-million dollar projects.
Project Management
Develop realistic and achievable time lines for product production. Able to independently or cooperatively manage individual projects to lighten your workload, or where you need some specific expertise. Leverage years of experience to reduce your projects risks and costs or to quickly estimate the cost of a project.
Quality
Directed QA/QC for small and large pharmaceutical companies.
Performed vendor audits, batch record review, complex product quality investigations, complaint investigations and CAPA. Performed Pre-approval inspections, managed warning letter and 483 remediation efforts. Release and stability testing oversight of small molecules. Methods development, validation and troubleshooting. OOS and OOT investigation management. Unknown identification and qualification. Stability data trending and justification of expiry/retest dating.
Regulatory
Expert CMC writer. Contributing CMC author to five NDA’s including three first round approvals. Experienced with the preparation of eCTD’s and MAA’s. Numerous IND’s, amendments, Annual Reports and PAS’s. Experienced with FDA interactions and in contributing/setting submission strategy successfully. Experience with 505(b)(2) and combination products.
Supply Chain
Experienced with vendor selection, vendor qualification, process transfer, process validation, product launch, forecasts, scale up and commercial support. Extensive experience in troubleshooting and resolving quality and manufacturing issues affecting the supply chain. Experience with cold chain planning and management.
Respiratory Products
Extensive small molecule CMC respiratory product development, testing and commercialization experience. Involved in two inhalation aerosol and two inhalation solution NDA’s with three first round approvals. Experienced in supporting the commercialization and launch of several respiratory products. Supported design, molding, validation and production of novel aerosol actuators and dose indicators. Developed and validated drug substance sterilization processes and manufacturing processes for an inhalation suspension.
Facilitation
Malone has worked with companies all over the world on a myriad of product development projects from raw materials to aseptically filled drug products. Let us put our connections in the U.S. and abroad to work for you.