News
All NewsBio/Pharma NewsIndustry NewsSupplier NewsEvents
Multimedia
All VideosAsk the ExpertBehind the HeadlinesBuy, Sell, HoldPeer ExchangePivotal Papers
Publication
Conferences
Conference ListingLatest Conference Content
More
Resources
Podcast SeriesBiopharma InsightsPartnersSponsored PodcastsSponsored VideosSponsored eBooksToolkitsWhitepapers
Webcasts

Subscribe

  • News
  • Multimedia
  • Publication
  • Conferences
  • Resources
  • Subscribe
  • Webcasts
  • BioBusiness
    • Partnerships
    • Funding and Investments
    • Intellectual Property & Patents
    • Biologic Drugs in Development
    • Mergers and Acquisitions
  • BioPharm Products
  • BioPharm Sponsored Ad
  • Biopharmaceutical Analysis
    • Analytical Best Practices
    • Analytical Methods
    • Lab Furnishings and Equipment
    • Contract Analytical Services
    • Finished Product Analysis
    • Drug Substance Analysis
    • Biopharmaceutical Analysis: GC-MS
    • Biopharmaceutical Analysis: Mass Spectrometry
    • Biopharmaceutical Analysis: ICP-MS
    • Biopharmaceutical Analysis: NMR
    • Biopharmaceutical Analysis: Raman
    • Biopharmaceutical Analysis: Gas Chromatography
    • Biopharmaceutical Analysis: LC-MS
    • Biopharmaceutical Analysis: HPLC/UHPLC
    • Analytical Instrumentation
  • Biosimilars and Biobetters
  • Deals, Development and Manufacturing
  • Development
    • Formulation
    • Process Validation
    • Drug Delivery
    • Process Development
    • Scale Up
    • Excipients
    • API Synthesis and Manufacturing, Large Molecule
    • Formulation and Drug Delivery, Combination Drugs
    • Early Phase Development
    • Formulation and Drug Delivery, Biologic Drugs
    • Formulation and Drug Delivery, Parenterals
    • Formulation and Drug Delivery, Specialty Dosage Forms
    • Formulation and Drug Delivery, Controlled Release
    • Formulation and Drug Delivery, Liquids
    • Formulation and Drug Delivery, Solid Dosage
    • Formulation and Drug Delivery, Other
  • Discovery Pipeline
  • Disposables Advisor
  • Downstream Processing
    • Viral Clearance
    • Manufacturing, Separation and Purification
    • Manufacturing Equipment, Downstream Processing
    • Manufacturing, Process Chromatography
  • Elements of Biopharmaceutical Production
  • From the CEO
  • From the Editor
  • Inside Standards
  • Interphex Keynote Sessions
  • Manufacturing
    • Manufacturing, Monoclonal Antibodies
    • Manufacturing Systems, Single-Use
    • Vaccine Development and Manufacturing
    • Manufacturing, Aseptic Processing
    • Manufacturing, Fill/Finish
    • Facility Design and Engineering
    • Process Control, Automation, and PAT
    • Supply Chain/Logistics
    • Manufacturing Best Practices
    • Information Technology
    • Technology Transfer
    • Manufacturing Equipment, Upstream Processing
    • Manufacturing Equipment, Biologics
    • Cleanroom Equipment and Supplies
    • Manufacturing, Parenterals and Injectables
    • Clinical Trial Materials
    • Manufacturing, Biosimilars and Biobetters
    • Manufacturing, Lyophilization
    • Manufacturing, Combination Drugs
    • Manufacturing, Solid Dosage Drugs
    • Manufacturing, Topical Drugs
    • Manufacturing, Biologics
    • Manufacturing, Specialty Dosage Forms
    • Manufacturing, Nucleic Acids
    • Manufacturing, Liquid Drug Products
    • Manufacturing, Drug Products
    • Manufacturing, Cell Therapies
    • Manufacturing, Recombinant Proteins
    • Manufacturing, Continuous Biologics Processing
    • Manufacturing, Gene Therapies
    • Packaging, Labeling, and Distribution Systems
  • Outsourcing
    • Clinical Trial Services
    • Perspectives on Outsourcing
    • Contract Services, Regulatory Consulting
    • Contract Packaging, Logistics, and Distribution
    • Contract Manufacturing, Sterile, Aseptic Processing
    • Contract Manufacturing, Biopharmaceutical Production
    • Contract Manufacturing, Drug Substance, API
    • Contract Manufacturing, Finished Drug Product
    • Contract Manufacturing, General
    • Contract Services, Formulation and Drug Delivery
  • Peer-Reviewed Research
  • Pharmacopoeial Compliance Series
  • Quality/GMPs
    • Ask the Expert
    • Regulatory/GMP Compliance
    • Compliance Notes
    • Regulatory Beat
    • European Regulatory Watch
    • Adverse Events and Recalls
    • Regulatory/GMP Compliance, Europe
    • Regulatory/GMP Compliance, Emerging Markets
    • Audits and Inspections
    • Anticounterfeiting, Track and Trace Systems
    • Quality by Design
    • Compendial Compliance
    • Standard Operating Procedures (SOPs)
    • Quality Control/Quality Assurance
    • Regulatory Filings and Submissions
    • Regulatory Authority Actions
  • Therapeutic Specific Areas
  • Upstream Processing
    • Manufacturing, Cell-Line Selection
    • Manufacturing, Expression Systems
    • Manufacturing, Cell Culture and Fermentation
  • Viewpoints
  • Weighing Up Big Pharma
Spotlight -
Analytics|
Development|
Downstream Processing|
Manufacturing|
Outsourcing|
Quality/GMPs|
Upstream Processing
Advertisement
|Articles|September 7, 2013

Compliance by Design and Compliance Master Plans

Video with Paul Pluta

Advertisement

Newsletter

Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.

Subscribe Now!
Advertisement

Related Content

Advertisement
A 3d rendering of the moment a nanocarrier or liposome delivers its therapeutic payload to a specific target or nervous system at a microscopic level. | Image credit: © Love Employee - © Love Employee - stock.adobe.com

FDA Clears PharmaResearch IND for Nano-Based Cancer Drug PRD-101

ByFeliza Mirasol
February 6th 2026
Abstract blue human heart with red cardio pulse line and red circle. Healthcare medical concept | Image credit: © Елена Бутусова - © Елена Бутусова - stock.adobe.com

FDA Clears Affinia’s AFTX-201 for Phase I/II BAG3 Cardiomyopathy Trial

ByFeliza Mirasol
February 4th 2026
Woman injects herself with the drug Ozempic anti-diabetes pen into her arm at home. Weight loss and decreased blood sugar, concept idea. injector dosing pen for subcutaneous injection | Image credit: © alones - © alones - stock.adobe.com

FDA Priority Review of Subcutaneous Lecanemab Signals Shift in Alzheimer’s Treatment Delivery

ByFeliza Mirasol
January 28th 2026
Antibody | Image credit: © Design Cells - © Design Cells - stock.adobe.com

FDA Fast Tracks Innovent’s Trispecific Antibody for Multiple Myeloma

ByFeliza Mirasol
January 28th 2026
Doctor making injection to senior patient in clinic | Image credit: © InsideCreativeHouse - © InsideCreativeHouse - stock.adobe.com

GSK’s Arexvy Gains EU Approval for Adults Aged 18 Years and Older

ByFeliza Mirasol
January 26th 2026
Advertisement
Advertisement

Trending on BioPharm International

1

How CDMO Alliances Can Provide End-to-End Service that Reduces Drug Development Time and Costs

2

FDA Clears PharmaResearch IND for Nano-Based Cancer Drug PRD-101

3

First-in-Human Study Validates Safety of Next-Generation mRNA–LNP Platform

4

High-Dose Nusinersen Slows Neurodegeneration in SMA Patients, Study Shows

5

Industry Outlook 2026: Key Forces Transforming Drug Pipelines (Part 2)

  • About Us
  • Advertise
  • Editorial Information
  • Contact Us
  • Do Not Sell My Personal Information
  • Privacy Policy
  • Terms and Conditions
Contact Info

259 Prospect Plains Rd, Bldg H
Cranbury, NJ 08512

609-716-7777

Brand Logo

© 2025 MJH Life Sciences®

All rights reserved.

Home
About Us
News
Contact Us