CTD – Page 2 – 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
Biopharmaceutical Consulting
BLA
Breakthrough Designations
Budget
CDMO
CDRH
cGMP
Chemistry
China
Clinical
Clinical Phase Appropriate
Clinical Studies
Clinical Trials
CMC
CMC strategy
CMO
Commercial Process
compatibility studies
Compliance
consulting services
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

September 16, 2021

Published by Meranda Parascandola at September 16, 2021

Starting Early: How to Ease the Process of a New Drug Application

Start early, document thoroughly. That’s the lesson for getting through the new drug application or biologics license application (NDA/BLA) process. Long before marketing approval, companies developing new products must apply to conduct clinical trials by submitting an investigational new drug (IND).

November 4, 2021

Published by Meranda Parascandola at November 4, 2021

How To Tell A Compelling CMC Story In Your NDA/BLA Application

Storytelling is integral to the pharmaceutical regulatory process. It’s really what your new drug application (NDA) or biologics license application (BLA) is all about. It’s about deciphering the data to tell a reviewer how your process and product works.