FDA NME & NCE

1. FDA NME & NCE Start Up, New Molecular Entities (NME) and New Chemical Entities (NCE) are high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective and consistent compilation of NME & NCE Product and Process Development for inclusion in the electronic submission can reduce costs and timelines. Effective cost and timeline reductions of NME & NCE electronic submissions are most likely achieved via proactive, early utilization of Drug Development

2. Services, 505(b) NDA, IND Consulting, NDA Consulting, BLA Consulting, and effective FDA Pre- Submission collectively resulting in FDA and Regulatory Body Clearance/Approval. The purpose of the electronic submission, as used by the FDA, is to expedite the validation of content and Clearance/Approval of: PIND Meeting Request, Review, and Response IND Pre NDA Meeting Request, Review, and Response NDA Pre ANDA Meeting Request, Review, and Response ANDA BLA DMF Combination Drugs Etc. Use of electronic submission process enables the rapid and seamless integration across and within each step in the NME & NCE Product and Process Development Lifecycle for your respective DS(s)/DP(s). The seamless use of the electronic submission process also requires proactive and early compliance with

3. Pharmaceutical Product and Process Science-Risk Based Characterization Principles. These begin with the early Target Product Profile, Risks, and Science which must continue to be traced throughout the entire Pharmaceutical Development Lifecycle, Post Market Surveillance, and Drug History File content and that are compiled into the electronic submission. As a result, successful utilization of the NME & NCE electronic submission process requires proactive, early utilization of Drug Development Services, 505(b) NDA, IND Consulting, NDA Consulting, BLA Consulting, and effective FDA Pre-Submission to collectively result in FDA and Regulatory Body Clearance/Approval. Proactive utilization of the NME & NCE electronic submission process via Drug Development Services, 505(b) NDA, IND Consulting, NDA Consulting, BLA Consulting, and effective FDA Pre-Submission will compliantly accelerate your seamless Pharmaceutical DS and DP Characterization Safety-Effectiveness-Risk- Rationale-Justification integration across and within each step in the Pharmaceutical Development-Manufacturing- Post Market Surveillance Lifecycle for your individual DS/DP essential to collectively result in FDA and Regulatory Body Clearance/Approval.

4. Author Information William E. Spanogle, Ph.D. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. He is a published ISPE Invitational author in Pharmaceutical and Biologics Product and Process Development and has presented and trained thousands of professionals on QbD, Design Controls, Science-Risk Based Product Characterization, and Risk Management at several international conferences and numerous private corporate sessions. Dr. Spanogle has taken scores of Regulated Life Science Products from discovery to approval and launch; and audited, identified, and remediated QMS deficiencies. Pharmaceutical Development Group (PDG) is a global scientific & regulatory consulting firm with extensive experience in the strategic development of drug products, biologics, medical devices, combination products and FDA regulatory affairs. PDG is a Regulated Life Sciences consulting group focusing on IND, ANDA, NDA, Biologics, and Medical Device regulatory services. PDG is a subsidiary of Biotech Research Group Corporation. The opinions and statements in this blog are those of the authors and do not necessarily reflect those of PDG. This

5. blog is based on personal experience and reviews of information publicly available or identified in other database searches.