Services.
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Essential Solutions Backed by Experience
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Strategic areas of service and mentorship include: Drawing simplified, easy to understand roadmaps for establishing QbD/PAT based development and manufacturing processes of pharmaceuticals, of either new or already approved products (Reference: ICH Guidelines 8, 9, 10, and 11)
We provide: formulations development (of Pharmaceuticals and Nutraceuticals) for IR, MR, and other unique and innovative dosage forms; and simplification of batch records, processes and controlled documentation for zero deviation during manufacturing We handle a Seamless Technology Transfer based on a Model of 10 Commandments which include logistics and technical guidance – Right at First Time We deliver practical and compliant approaches for “Molecule to Market” and “Life Cycle Management (LCM) for significant timeline and fiscal resource reduction We research an appropriate API sourcing for you to meet your specific needs based on product profile you would like to develop and manufacture PCS conveys complete and comprehensive directions for Quality Management System (QMS) and Quality Risk Management (QRM) during entire Life Cycle Management (LCM) of the product Focused areas of support and quality for cGMP and FDA compliance include: providing scaffolding for 21st Century Quality Initiatives of FDA for QbR, QbD, & PAT (ICH GL 8,9, 10 and 11); delivering customized stepwise strategies for developing robust manufacturing; SOP creation and review; GMP compliance (deviation, CAPA, Change Control, complaint, and Audit) We assist in establishing Quality Metrics, writing technical quality agreements, and auditing of API, excipient, and manufacturing facilities in US, India, or RoW to comply with cGMP regulations |
Your Education
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Pharma Consulting Services provides tailored training for a variety of subjects in several modalities. Some of the topic include:
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We Promise You the BestEdit this text and tell your site visitors who you are. To edit, simply click directly on the text and add your own words. Use this text to go into more detail about your company. Make sure to include information about how your company came to be. A strong “About” page helps establish credibility and professionalism and lets the visitor know more about you.
Make sure to include information about how your company came to be. A strong “About” page helps establish credibility and professionalism and lets the visitor know more about you. |