Login
Join
FOLLOW:
Subscribe Free
Magazine
eNewsletter
Checkout
Menu
Magazine
News
Manufacturing
Packaging
Development
Compliance
Top 20
Directory
Solution Center
Events
More
Magazine
News
Manufacturing
Packaging
Development
Compliance
Top 20
Directory
Solution Center
Events
Current / Back Issue
Features
Editorial
Columns
Digital Edition
eNewsletter Archive
Our Team
Editorial Guidelines
Subscribe Now
Advertise Now
Top Features
Working in Tandem: Effective Security for Weight-loss Drug Packaging
Navigating Global CDMO Trends
Anti-Counterfeiting Technology
Making the Most of Real-World Data in Clinical Trials
Inflation Reduction Act and the Impact on Biosimilars
Breaking News
Online Exclusives
Industry News
Collaborations & Alliances
Promotions & Moves
Trials & Filings
Financial Reports
Bio News & Views
Custom Sourcing News
Packaging & Tracking
CRO News
Live From Shows
Top News
Mosaic ImmunoEngineering to Acquire the Rights to Oncotelic’s Clinical-Stage Cancer Therapies
Evox Therapeutics Taps Dr. Per Lundin as CEO
Ono Pharmaceutical to Acquire Deciphera for $2.4B
MiLaboratories, Miltenyi Biotec Enter Genomics Alliance
Alentis Names Dr. Alberto Toso as Chief Scientific Officer
APIs
Aseptic Processing
Cleaning Validation
Clinical Trial Materials
Cytotoxics and High Potency Manufacturing
Equipment
Excipients
Extractables and Leachables
Facilities
Fill/Finish
Lyophilization
Parenterals
Process Development
Process Validation
Risk Management
Scale-up/ Technology Transfer
Solid Dosage/ Creams/ Ointments
Mosaic ImmunoEngineering to Acquire the Rights to Oncotelic’s Clinical-Stage Cancer Therapies
Lonza Introduces AI-Enabled Route Scouting Service
[WEBINAR] Mitigating Supply Chain Risks in an Age of Disruption
Multiply Labs and GenScript Partner to Automate Cell Isolation
FibroBiologics Discusses Opportunities to Work with Charles River
Capsules
Cold Chain Management
Injectables
Logistics
Serialization
Solid Dosage / Semi-solids
Supply Chain
Vials
[WEBINAR] Mitigating Supply Chain Risks in an Age of Disruption
Tower Cold Chain Introduces KTEvolution 12 Containers
Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model
[WEBINAR] Headspace Gas Ingress Methods - The Golden Tool for Container Closure Integrity Testing
[WEBINAR] Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model
Analytical Services
Bioanalytical Services
Bioassay Developement
Biologics, Proteins, Vaccines
Biosimilars
Chemistry
Clinical Trials
Drug Delivery
Drug Development
Drug Discovery
Formulation Development
Information Technology
Laboratory Testing
Methods Development
Microbiology
Preclinical Outsourcing
R&D
Toxicology
Evox Therapeutics Taps Dr. Per Lundin as CEO
Ono Pharmaceutical to Acquire Deciphera for $2.4B
MiLaboratories, Miltenyi Biotec Enter Genomics Alliance
Alentis Names Dr. Alberto Toso as Chief Scientific Officer
BMS, Repertoire Immune Medicines Enter Strategic Autoimmune Vax Pact
Filtration & Purification
GMPs/GCPs
Inspections
QA/QC
Regulatory Affairs
Validation
Cellares Launches Cell Q Automated cGMP QC Workcell for Cell Therapies
TATAA Biocenter Awarded GLP Accreditation
Anti-Counterfeiting Technology
Do You Know Your Product's Impurity Profile?
Inflation Reduction Act and the Impact on Biosimilars
Companies
Categories
Corporate Capabilities
Add New Company
Contract Service Directory Companies
CMC Pharmaceuticals
LOTTE BIOLOGICS
Abzena
SUANFARMA CDMO
Syngene International Ltd.
Companies
News Releases
Posters
Brochures
Services
Videos
Case Study
White Papers
Jobs
Contract Service Directory Companies
CMC Pharmaceuticals
LOTTE BIOLOGICS
Abzena
SUANFARMA CDMO
Syngene International Ltd.
Webinars
Live From Shows
Magazine
Current / Back Issue
Features
Editorial
Columns
Editorial Guidelines
Subscribe Now
Advertise Now
Enewsletter Archive
Digital Edition
Directory
Companies
Categories
Corporate Capabilities
Add Your Company
Manufacturing
APIs
Aseptic Processing
Cleaning Validation
Clinical Trial Materials
Cytotoxics and High Potency Manufacturing
Equipment
Excipients
Extractables and Leachables
Facilities
Fill/Finish
Lyophilization
Parenterals
Process Development
Process Validation
Risk Management
Scale-up/ Technology Transfer
Solid Dosage/ Creams/ Ointments
cGMP Manufacture
Packaging
Capsules
Cold Chain Management
Injectables
Logistics
Serialization
Solid Dosage / Semi-solids
Supply Chain
Vials
Development
Analytical Services
Bioanalytical Services
Bioassay Developement
Biologics, Proteins, Vaccines
Biosimilars
Chemistry
Clinical Trials
Drug Delivery
Drug Development
Drug Discovery
Formulation Development
Information Technology
Laboratory Testing
Methods Development
Microbiology
Preclinical Outsourcing
R&D
Toxicology
Compliance
Filtration & Purification
GMPs/GCPs
Inspections
QA/QC
Regulatory Affairs
Validation
Top 20 Pharma & BioPharma
Contract Pharma Direct
Breaking News
Online Exclusives
Slideshows
Experts Opinions
Surveys
Outsourcing Survey
Salary Survey
Glossary
Videos
White Papers
Podcasts
Infographics
Microsites
Companies
News Releases
Posters
Brochures
Services
Videos
Case Study
White Papers
Contract Pharma Conference
Contract Pharma Conference
Speakers
Exhibitors
Conference Sessions
eBook
Webinars
Events
Industry Events
Live from Show Events
Webinars
Classifieds / Job Bank
Classifieds
Job Bank
About Us
About Us
Contact Us
Advertise With Us
Privacy Policy
Terms of Use
FDA Watch
All
Drug Discovery and Development
Contract Manufacturing
Packaging
Compliance
Analytical Services
|
Bioanalytical Services
|
Laboratory Testing
|
QA/QC
Considerations When Outsourcing Stability Testing
Stability studies are a critical element of drug development and a key commitment in maintaining product on the market.
Paul Mason, Lachman Consultants
09.13.22
Information Technology
|
QA/QC
|
Regulatory Affairs
Data Governance for Outsourced Facilities Management Services
Data integrity is a growing and mainstream concern within the pharmaceutical industry.
Scott Deckebach, Director & Patrick Day, Principal Consultant, Lachman Consultants
06.07.22
Biologics, Proteins, Vaccines
|
Regulatory Affairs
Phase-Appropriate cGMP Considerations for Cell and Gene Therapy
Readiness to begin GMP manufacturing is a decision point that requires careful consideration.
Keith Lamb, Executive Director, Lachman Consultants
05.02.22
Information Technology
|
QA/QC
|
Regulatory Affairs
The Importance of Data Integrity Risk Assessment
Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.
Paul Mason, Ph.D., Lachman Consultants
06.07.21
Drug Delivery
The Ever-Evolving World of Combination Products
Looking at the benefits and challenges of the trend towards combination products.
Ricki A. Chase, M.S, Lachman Consultants
04.01.21
Solid Dosage/Creams/Ointments
Recent Advances in Solid Dispersion Technologies
Improving the bioavailability and therapeutic efficiency of poorly soluble drugs.
José L. Toro, Directory, Lachman Consultants
01.27.21
The Importance of Hypothesis Testing During Investigations
Why it is critical to have controls in place during out-of-specification investigations to provide quality assurance.
Paul Mason, PhD, Lachman Consultants
11.17.20
Biologics, Proteins, Vaccines
|
Regulatory Affairs
Ensuring Manufacturing Continuity for Essential Medicines
Applying the principles of Quality Risk Management to get medicines to market faster.
John Darby, M.Sc., Senior Director, Lachman Consultant Services, Inc.
09.09.20
Biologics, Proteins, Vaccines
Pharma’s Fight Against the Coronavirus Pandemic
A look at the pharma industry’s concerted effort to develop vaccines against the SARS-CoV-2 virus and therapeutics to treat COVID-19.
Keith O. Webber, Lachman Consultant Services, Inc.
07.15.20
Information Technology
|
Regulatory Affairs
Data Integrity: Beyond Electronic Records
Get your Data Integrity house in order
Tim Rhines, Ph.D., Director, Lachman Consultant Services, Inc.
05.05.20
Regulatory Affairs
Inquiring Minds Want to Know, Just Ask FDA
What you need to know prior to submission
Michelle Ryder, Lachman Consultant
04.01.20
Regulatory Affairs
The Art of Filing NDA/ANDA Post-Approval Changes to the FDA
Some tips to make your trip along the regulatory pathway to report manufacturing changes easier.
Amy Schutte, Senior Associate, Lachman Consultant Services
03.04.20
Regulatory Affairs
Inactive Ingredients: Where Guidance Needs to Meet Data
Looking at FDA’s most recent draft guidance and the struggle with inactive ingredients.
Sharif Ahmed, Lachman Consultants Services
10.15.19
Regulatory Affairs
Continuous Manufacturing and its Regulatory Challenge
...
José L. Toro, PhD, Lachman Consultants
09.16.19
QA/QC
|
Validation
Considerations for Analytical Method Validation Lifecycle Controls
ICH is set to implement new regulatory guidance dedicated to analytical method development
Paul Mason, PhD, Lachman Consultants
07.15.19
Regulatory Affairs
Effective Post Market Supplier Strategy for Combination Products
Combinations are typically designed, developed and maintained under a robust contract manufacturing process
Lori-Ann Woodard CBA, CQE, CSQE, Lachman Consultant Services
06.13.19
QA/QC
Nitrosamines
How to address these unwelcome guests in the pharmaceutical world
Aloka Srinivasan, Ph.D., Lachman Consultant Services
05.07.19
Regulatory Affairs
KASA to Support Generic Drug Review
FDA expects the new system to advance OPQ’s focus on pharmaceutical quality, the foundation for ensuring the safety and efficacy of drugs.
Sharif Ahmed, Lachman Consultant Services
04.05.19
Regulatory Affairs
FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition an
A look at how the FDA will administer the transition of NDAs to BLAs
Keith Webber, Ph.D., Lachman Consultant Services
03.06.19
Regulatory Affairs
Reporting CPPs to FDA
Importance of identifying critical process parameters in original submissions to FDA.
Aloka Srinivasan, Ph.D. Lachman, Consultant Services
10.10.18
Breaking News
Mosaic ImmunoEngineering to Acquire the Rights to Oncotelic’s Clinical-Stage Cancer Therapies
Evox Therapeutics Taps Dr. Per Lundin as CEO
Ono Pharmaceutical to Acquire Deciphera for $2.4B
MiLaboratories, Miltenyi Biotec Enter Genomics Alliance
Alentis Names Dr. Alberto Toso as Chief Scientific Officer
View Breaking News >
CURRENT ISSUE
April 2024
Anti-Counterfeiting Technology
Navigating Global CDMO Trends
Weight-loss Drug Packaging
Clinical Supply CDMOs
Industry Experts Weigh in on Oral Solid Dosage
Newsmakers Q&A: Almac Group
Economical Mobile Workstations for Lower-Grade Cleanrooms
Pharmaceutical Manufacturing Equipment & Trends
Insight Into Obesity-Related Clinical Research
Inflation Reduction Act and the Impact on Biosimilars
View More >