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. Read https://pharmdevgroup.com/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.