Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars 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 use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting, NDA Consulting, BLA Consulting, and effective FDA Pre-Submission collectively resulting in FDA Approval.
The purpose of the term “Data Standards”, as used by the FDA is to:
- Develop well-defined, publicly available data standards
- Ensure that data is submitted according to publicized standards
- Develop Advanced review tools so that FDA reviewers can use standardized data efficiently and effectively (example: FDA CARB, etc).
Use of Data Standards enable the seamless integration across and within each Stage and/or Phase of the Product Development Lifecycle for your individual Product(s) as well as any comparative or RLD Product(s).
The seamless use of Data Standards also require compliance with Data Integrity Standards. Seamless application of Data Standards, Data Integrity, begins no later than DMPK Protocols and all other Data filed in the Drug History File and used in the CMC.
As a result proactive utilization of Data Standards and Data Integrity expertise via Drug Development Services, 505(b) NDA, IND Consulting, NDA Consulting, BLA Consulting, and effective FDA Pre-Submission are essential to collectively result in FDA Approval.
Proactive utilization of Data Standards and Data Integrity expertise via Drug Development Services, 505(b) NDA, IND Consulting, NDA Consulting, BLA Consulting, and effective FDA Pre-Submission will compliantly accelerate your seamless Data-Safety-Effectiveness-Risk-Rationale-Justification integration across and within each Stage and/or Phase and Submissions throughout your Product Development Lifecycle and that of any comparative or RLD Product(s) essential to collectively result in FDA Approval.
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 blog is based on personal experience and reviews of information publicly available or identified in other database searches.