Outsourcing – DSI InPharmatics

Filter by
Categories
Tags
Authors
Show all

All
Blogs
DSI Podcast
Homepage
Medical Devices
News
Pharma IT
Supply Chain
Thought Leadership
Veterinary Medicine

All
AAPS
Acceleration
Agencies
Analytical Methods
Animal Health
API
Application
Audit
Audit Report
Authoring
batch
Batches
Biologics
Biologics Consulting
BLA
Breakthrough Designations
Budget
CDRH
cGMP
Chemistry
China
Clinical
Clinical Phase Appropriate
Clinical Studies
Clinical Trials
CMC
CMC strategy
CMO
Commercial Process
compatibility studies
Compliance
Container Closure Systems
Contract Manufacturing
Controls
Covid
CPP
CPPs
CQA
CQAs
CRL
CTD
development
Device
document
Drug Development
Drug Formulation
Drug Life Cycle
Drug Product
Drug Substance
Early Stage
EMA
emerging
Emerging Biotech
End of Phase 2
EOP2
Expedited Development
Experts
Extractables
FD&C
FDA
filing
Filing Strategy
Filter Validation
filters
Format
Formulation Development
gap analysis
GMP
ICH
Impurities
IND
injections
Key Variables
Living Document
MAH
Manufacturing
Material Characterization
Material Selection
Medical Device
Meetings
Microbiology
Module 3
Module3
molecule
Molecule Assessment
NCE
NDA
Nitrosamine
objectives
Operations
Oral Solid Dose
Orphan Drug
Outsourcing
parenteral
PDA
Person-In-Plant
Phase 1
Phase 2
Phase 3
pilot
Planning
Podcast
Pre-IND
Process Development
Process Validation
Project Management
QbD
QMS
QOS
QPPV
QTPP
Quality
Quality Assurance
Quality Control
Registration
Regulations
Regulatory
Regulatory Affairs
Regulatory Odd Couple Series
Regulatory Sciences
Regulatory Submissions
report
Requirements
Review
Reviewers Guide
Risk
Risk Assesment
risk assessment
ROI
SDP
solvent
Sponsor
Sponsors
Stability
sterile product
sterilization
Strategy
Submission
Templates
Validation
Vendors
Virtual Audit
Virtual Audits

All
Meranda Parascandola

April 15, 2021

Published by Meranda Parascandola at April 15, 2021

Material Characterization and Formulation Development

Learn how to guide sponsors in the critical exercise of materials characterization and the establishment of reference standards for NCEs as well as in the formulation of drug products from the IND-enabling stages of development through postapproval evergreening changes.

January 19, 2022

Published by Meranda Parascandola at January 19, 2022

The Pros and Cons of Outsourcing Manufacturing to China

Trust is important when selecting a contract manufacturing organization (CMO), particularly when offshoring. With more biopharmaceutical companies looking to China-based CMOs, companies need to understand both the opportunities and the challenges the market presents.