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Top Features
Seven Core Pieces of the Puzzle: What to Consider When Selecting an Analytical Lab
Bridging the Divide: Understanding Contrasting Approaches in Drug Development
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FDA Approves Roche's Itovebi for Breast Cancer
Evonik to Restructure Keto and Pharma Amino Acid Business
Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Cellipont Bioservices, Mongoose Bio Partner to Advance MGB-001
Lipocine Enters Exclusive Supply and Distribution Agreement with Pharmalink
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Application of QbD Approach for Tech Transfer and Process Characterization of Biologics
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Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Cellipont Bioservices, Mongoose Bio Partner to Advance MGB-001
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Panthera Biopartners Joins Parexel Site Alliance Vaccine Network
Lilly, insitro Enter Strategic Agreements for Metabolic Diseases
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Rottendorf Pharma Selects ValGenesis VLMS
FDA sIRB Mandate: A Chance to Reassess Site Performance
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Inspections
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Filtration & Purification
GMPs/GCPs
Inspections
QA/QC
Regulatory Affairs
Validation
Analytical Services
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Bioanalytical Services
|
Breaking News
|
Facilities
|
Industry News
|
Inspections
Pace Life Sciences Completes Successful FDA Inspection of Operations in Oakdale, MN
Proven track record of consistent high quality confirmed at Pace Life Sciences’ headquarters.
07.25.24
Breaking News
|
cGMP Manufacture
|
Industry News
|
Inspections
|
Solid Dosage/Creams/Ointments
Almac Completes FDA Inspection at Charnwood, UK Facilities
Pre-approval inspection was related to a solid oral dose product which the site will manufacture for a global pharmaceutical company.
07.25.24
Breaking News
|
Facilities
|
Industry News
|
Inspections
|
Regulatory Affairs
|
Validation
Upperton Pharma Gains MHRA Approval at Nottingham Facility
The facility gives the green light to support clients from formulation development to late-phase clinical manufacture and product registration.
07.18.24
Inspections
|
Regulatory Affairs
Regulatory Affairs: A Common Warning Letter Citation Explored
Insights from the regulatory experts at Lachman Consultants.
Tony Polletta, Lachman Consultants
05.17.24
Aseptic Processing
|
Fill/Finish
|
Inspections
|
Parenterals
|
QA/QC
GRAM: Ensuring Quality Through Vigorous Finished Product Inspections
A Q&A with Brian Korson, director of finishing operations at Grand River Aseptic Manufacturing.
Sponsored
released by
Grand River Aseptic Manufacturing
03.27.24
Inspections
|
QA/QC
|
Regulatory Affairs
Regulatory Affairs: FDA’s Office of Compliance Issues FY 2023 Annual Report
Issued 170 warning letters and monitored 264 drug recall events during the year.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
02.01.24
Breaking News
|
Facilities
|
GMPs/GCPs
|
Industry News
|
Inspections
|
QA/QC
Crystal Formulations Services Passes EU QP Audit
Crystal Pharmatech’s CDMO business unit poised for global growth.
01.31.24
Inspections
|
Regulatory Affairs
FDA Inspections & Compliance Trends
A look back at 2023 and what 2024 will bring.
Online Exclusives
Ben Locwin , Contributing Writer
01.26.24
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Industry News
|
Inspections
|
QA/QC
FDA Finds QC Failures at Moderna's Norwood Mfg. Facility
Form 483 report obtained by Reuters notes five separate observations including equipment issues and expired items.
12.18.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Facilities
|
Industry News
|
Inspections
|
QA/QC
WuXi Vaccines Clears First GMP Audit
Resulted in no critical observations and will allow WuXi Vaccines to proceed with GMP manufacturing for the client's projects.
12.13.23
Breaking News
|
GMPs/GCPs
|
Industry News
|
Inspections
|
QA/QC
Intas Pharmaceuticals Receives Another Warning Letter from FDA
Cites failure to ensure drug products manufactured at Gujarat, India plant comply with cGMP.
12.01.23
Biologics, Proteins, Vaccines
|
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Fill/Finish
|
GMPs/GCPs
|
Industry News
|
Inspections
|
QA/QC
Symbiosis Granted MHRA License Following Expansion
Adds 3,600 ft² of new space, expanding GMP operational footprint at Stirling Innovation Park in Scotland.
11.21.23
Breaking News
|
cGMP Manufacture
|
Industry News
|
Inspections
Vetter’s Rankweil Site Receives Permanent Manufacturer’s Authorization
Austrian site supports manufacturing and quality control of Human Investigational Medicinal Products.
11.09.23
cGMP Manufacture
|
GMPs/GCPs
|
Inspections
Get Ready for a New Approach to cGMP Inspections
ANDAs, Biosimilars, BLA, FDA, Generics, NDA Regulatory Affairs
Bob Kelly, Principal Consultant, Lachman Consultant Services, Inc.
10.27.23
Breaking News
|
Drug Development
|
Drug Discovery
|
Facilities
|
Industry News
|
Inspections
Dipharma Receives 2nd GMP Certification from Brazilian ANVISA
The Caronno Pertusella site is the second Dipharma facility to receive ANVISA certification.
10.26.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Industry News
|
Inspections
Quotient Sciences Concludes FDA Inspection of UK Facility
For the validation of three bioequivalence studies supporting licensing applications with the FDA.
10.05.23
Breaking News
|
cGMP Manufacture
|
Drug Development
|
Facilities
|
Industry News
|
Inspections
Rentschler Biopharma’s ATMP UK Facility Receives MHRA Approval
Facility offers services from early process and analytical development through cGMP manufacturing for clinical trials.
09.13.23
APIs
|
Breaking News
|
cGMP Manufacture
|
Facilities
|
Industry News
|
Inspections
Aurisco's Manufacturing Site in China Clears FDA Inspection
Site offers CDMO services and generic APIs.
08.23.23
APIs
|
cGMP Manufacture
|
Facilities
|
Industry News
|
Inspections
|
QA/QC
Understanding the Causes & Impact of Drug Scarcity
The reasons behind drug shortages can range from supply and demand, manufacturing and regulatory issues, to discontinuations.
Online Exclusives
Kristin Brooks, Managing Editor, Contract Pharma
08.08.23
Inspections
|
QA/QC
|
Regulatory Affairs
FDA 2023 Inspection Roadmap: Is “Readiness” in Your Annual Objectives?
Insights from the regulatory experts at Lachman Consultants.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
05.25.23
Breaking News
FDA Approves Roche's Itovebi for Breast Cancer
Evonik to Restructure Keto and Pharma Amino Acid Business
Hubble Therapeutics Selects Andelyn to Manufacture Clinical Grade AAV
Cellipont Bioservices, Mongoose Bio Partner to Advance MGB-001
Lipocine Enters Exclusive Supply and Distribution Agreement with Pharmalink
View Breaking News >
CURRENT ISSUE
September 2024
Seven Core Pieces of the Puzzle: What to Consider When Selecting an Analytical Lab
Bridging the Divide: Understanding Contrasting Approaches in Drug Development
Updates on the Value of a Day of Delay in Drug Development
CEO Spotlight: Matthew Stober
CDMO Specialization
Post-COVID Trends in Biopharma Contract Manufacturing
Pharma’s Next Frontier: GLP-1s and Other New Therapies
CEO Spotlight: Prasad Raje
HPAPIs Soar Riding the Targeted Drugs Wave
View More >