What We Do
Regulatory Consulting & Compliance Support
Regulatory Consulting & Compliance Support
Regulatory Consulting & Compliance Support
- CMC Documentation Strategy
- Gap Analyses
- Due Diligence Audits / Technology Assessments.
- Form 483 Response Preparation / Management
- Annual Reports / PAS / CBE x Preparation
- Data Integrity and Compliance Audits to cGMPs (21 CFR Parts 210 and 211)
- OOS Investigation Documentation
- Laboratory and Quality Process Mapping
- Standard Operating Procedures
- Technical Staff Development and Training
Analytical Development Program Management
Regulatory Consulting & Compliance Support
Regulatory Consulting & Compliance Support
- Project Management / Vendor Management
- Material Change Protocols
- Controlled Extraction Study Design
- Extractables Identification and Data Analyses
- Extractables Methods Development and Validation
- Leachables Stability Program Design
- Leachables Methods Development and Validation
- Leachables Identification and Qualification Strategies
- Analytical Metho
- Project Management / Vendor Management
- Material Change Protocols
- Controlled Extraction Study Design
- Extractables Identification and Data Analyses
- Extractables Methods Development and Validation
- Leachables Stability Program Design
- Leachables Methods Development and Validation
- Leachables Identification and Qualification Strategies
- Analytical Methods Development and Validation Protocols
- Analytical Methods Remediation Strategies
- Impurity and Degradation Product Identification and Control Strategies
- Stability Study Design and Protocol Development
- Contract Laboratory Vendor Selection and Management
Patent Litigation Services
Regulatory Consulting & Compliance Support
Patent Litigation Services
- Patent Infringement Defense or Challenge Analytical Chemistry Expert Services
- Patent Infringement Defense or Challenge Packaging Compatibility Expert Services
Our Team
Thomas N. Feinberg - Managing Director
Dr. Thomas Feinberg is the Managing Director of Feinberg Norwood & Associates as a science-based consulting resource focused on helping clients find solutions for difficult analytical chemistry problems such as extract extractables leachables ables and leachables. In 2014 he founded SCIO Analytical which was re-branded in 2019 as FNA Pharma Consulting. Prior to SCIO Analytical, Dr. Feinberg worked for four years at the University of North Carolina at Chapel Hill in Chemistry and Environmental Sciences followed by a two-decade career at the Morrisville, North Carolina site of Catalent Pharma Solutions (formerly Cardinal Health and Magellan Laboratories). As the first LC-MS chemist at Magellan, he grew the Structural Chemistry function to become the industry leader in CMC support laboratory services for small molecule investigations with a specialty in designing and conducting extractables and leachables studies for MDI, DPI, ophthalmic, sterile, and topical drug products. Dr. Feinberg is internationally recognized, serving as an active member of the Product Quality Research Institute (PQRI) since 2001 and was a member of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS) since 2012. Dr. Feinberg completed his bachelor’s degree in Chemistry at Cornell University and his doctorate degree in Physical Chemistry at the University of North Carolina at Chapel Hill.
Daniel L. Norwood - Principal Consultant
Dr. Daniel Norwood has been with Feinberg Norwood & Associates from the inception and was the Executive Director of its predecessor, SCIO Analytical as Executive Partner since June 2015. Prior to SCIO Analytical, Dr. Norwood was a key technical employee at Boehringer Ingelheim Pharmaceuticals where he was successful in various pharmaceutical development roles, including Director Physical and Chemical Analysis. In June 2015, Dr. Norwood retired with the title of Distinguished Research Fellow in Analytical Development. Prior to joining Boehringer Ingelheim, Dr. Norwood, with Dr. Feinberg, founded the Structural Chemistry Group at Magellan Laboratories, later Catalent Pharma Solutions, which became widely recognized for its work in pharmaceutical impurity structure elucidation, and in leachables and extractables characterization. Prior to Magellan, he was a pharmaceutical development scientist at the Glaxo Research Institute. Dr. Norwood is an internationally recognized expert in the field of leachables and extractables assessment in pharmaceutical development and manufacturing. He served as chair of the widely-quoted Product Quality Research Institute (PQRI) Working Group on leachables and extractables in inhalation drug products. He is also a member of the PQRI Working Group on leachables and extractables in parenteral and ophthalmic drug products (PODP), and has served on various technical teams of the International Pharmaceutical Aerosol Consortium on Regulations and Science (IPAC-RS). Since 2010, he has served as a member of the USP Expert Committee on Packaging, Storage and Distribution where he chairs the subcommittee on extractables and leachables. Dr. Norwood has received several industry awards, including the CEO’s Award from Glaxo (1994), the President’s Award from Boehringer Ingelheim (2007), the Excellence in Research Award from PQRI (2009), and the Award for an Innovative Response to Public Health Challenges from USP (2013). Dr. Norwood completed his bachelor’s degree in Biochemistry at Virginia Tech and his doctorate degree in Environmental Chemistry at the University of North Carolina at Chapel Hill, School of Public Health.