• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Bye-Bye China?

    Decentralized Trials Fuel AI Revolution in Clinical Research

    Self-Medication: Flexibility for Patients and Drug Manufacturers

    The Single-Use Mixing Landscape: Evaluating Your Options

    DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    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
    Civica to Build an Essential Medicines Manufacturing Facility in Virginia

    Humanigen, Emergent Enter Covid-19 Partnership

    Samsung Bioepis Opens New Headquarters

    Pfizer, BioNTech Enter Vax Pact with COVAX

    FDA Approves Janssen’s CABENUVA
    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

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia

    Humanigen, Emergent Enter Covid-19 Partnership

    Samsung Bioepis Opens New Headquarters

    Integrated Continuous Manufacturing ICM

    CONTINUUS Awarded $69.3M DoD Grant
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia

    WDSrx Expands Warehouse Network

    Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

    Varcode, PL Developments Form Strategic ‘Smart Tag’ Pact

    COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge
    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

    Humanigen, Emergent Enter Covid-19 Partnership

    Samsung Bioepis Opens New Headquarters

    Lilly Completes $1B Acquisition of Prevail

    Top BioPharma Form Accumulus Synergy

    Coating Place Wurster Fluid Bed Process Scaling
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Adare Pharma Solutions

    Baxter BioPharma Solutions

    Alcami

    Aphena Pharma Solutions

    Emergent BioSolutions
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Emergent BioSolutions

    Baxter BioPharma Solutions

    Aphena Pharma Solutions

    Almac Group

    Adare Pharma Solutions
    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 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • 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
    Breaking News

    Parexel Launches COVID-19 Risk Mitigation Offering

    Four-step methodology aims ensure manufacturers can safely continue manufacturing operations through the COVID-19 pandemic

    Related CONTENT
    • Humanigen, Emergent Enter Covid-19 Partnership
    • Catalent Acquires Acorda’s INBRIJA Manufacturing Operations
    • Passage Bio Invests in Gene Therapy Manufacturing R&D Site
    • Passage Bio, Catalent Begin cGMP Mfg. for Gene Therapies
    • Frontida BioPharm Appoints Chief Financial Officer
    Contract Pharma Staff05.13.20
    Parexel has launched a COVID-19 Risk Mitigation offering leveraging its experience with global viral outbreaks as well as cGMP inspection and CMC review processes to help manufacturers safely continue operations through the COVID-19 pandemic.

    Parexel’s regulatory experts will partner with life sciences companies to help ensure business continuity by analyzing manufacturing operations to reduce the risk of viral contamination. The four-step methodology, including risk assessment, development of a risk mitigation action plan, implementation of solutions and routine re-assessment, aims to ensure companies are supported over time and as circumstances change or new risks arise.

    Parexel will leverage its experience in mitigating viral transmission cross contamination gained from experience at global health authorities, including MHRA’s Inspection, Enforcement and Standards Division and FDA/CDER’s Office of Pharmaceutical Quality, Office of Process and Facilities. The company’s Regulatory & Access team includes more than 1,000 on-staff consultants worldwide, including 80+ former regulators and inspectors who have extensive knowledge of GxP, CMC and cGMP review and inspections.

    “COVID-19 has impacted just about every aspect of drug development and manufacturing, yet at the same time we must deliver on our promises to the patients who are awaiting new therapies every day,” said Peyton Howell, Executive Vice President and Chief Commercial & Strategy Officer. “Safely and successfully ensuring an uninterrupted supply of pharmaceutical and device products will be key to maintaining the development and delivery of new medicines for patients throughout the pandemic.”

    Suggested For You
    Humanigen, Emergent Enter Covid-19 Partnership Humanigen, Emergent Enter Covid-19 Partnership
    Catalent Acquires Acorda’s INBRIJA Manufacturing Operations Catalent Acquires Acorda’s INBRIJA Manufacturing Operations
    Passage Bio Invests in Gene Therapy Manufacturing R&D Site Passage Bio Invests in Gene Therapy Manufacturing R&D Site
    Passage Bio, Catalent Begin cGMP Mfg. for Gene Therapies Passage Bio, Catalent Begin cGMP Mfg. for Gene Therapies
    Frontida BioPharm Appoints Chief Financial Officer Frontida BioPharm Appoints Chief Financial Officer
    KBI Biopharma Expands U.S. Ops KBI Biopharma Expands U.S. Ops
    Albemarle Corporation Albemarle Corporation
    Life Science Success Podcast: Matt Hicks Life Science Success Podcast: Matt Hicks
    Baxter Invests $50M to Expand Sterile Fill/Finish Manufacturing Operations Baxter Invests $50M to Expand Sterile Fill/Finish Manufacturing Operations
    MedPharm MedPharm
    Eisai Invests in New Packaging Lines Eisai Invests in New Packaging Lines
    LGM Pharma LGM Pharma
    TCR² Therapeutics, ElevateBio Expand TC-210 Mfg. Capacity TCR² Therapeutics, ElevateBio Expand TC-210 Mfg. Capacity
    Pharmaceutical Logistics Company Expands in San Antonio Pharmaceutical Logistics Company Expands in San Antonio
    TFF Expands Engagement with Experic TFF Expands Engagement with Experic

    Related Breaking News

    • Breaking News | Facilities | Industry News | Injectables | Parenterals
      Civica to Build an Essential Medicines Manufacturing Facility in Virginia

      Civica to Build an Essential Medicines Manufacturing Facility in Virginia

      Will produce sterile injectable meds used in hospitals for COVID-19 patient care.
      Tim Wright, Editor, Contract Pharma 01.25.21

    • Bio News | Breaking News | Clinical Trial Materials | Clinical Trials | Collaborations & Alliances | Industry News
      Humanigen, Emergent Enter Covid-19 Partnership

      Humanigen, Emergent Enter Covid-19 Partnership

      Sign contract development and manufacturing agreement for Phase 3 COVID-19 therapeutic candidate lenzilumab.
      Tim Wright, Editor, Contract Pharma 01.25.21

    • Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Facilities | Industry News
      Samsung Bioepis Opens New Headquarters

      Samsung Bioepis Opens New Headquarters

      The 52,000-square-foot campus to become the hub of Samsung Bioepis’ drive for accelerated development of next-gen biologic medicines.
      Tim Wright, Editor, Contract Pharma 01.25.21


    • Breaking News | Industry News
      Pfizer, BioNTech Enter Vax Pact with COVAX

      Pfizer, BioNTech Enter Vax Pact with COVAX

      Initial agreement provides up to 40 million doses of the Pfizer-BioNTech COVID-19 Vaccine to COVAX in 2021, with first deliveries expected in 1Q21.
      Kristin Brooks 01.22.21

    • Breaking News | Trials & Filings
      FDA Approves Janssen’s CABENUVA

      FDA Approves Janssen’s CABENUVA

      Becomes first and only once-monthly, long-acting regimen for the treatment of HIV infection.
      Kristin Brooks 01.22.21

    • Breaking News | Promotions & Moves
      AGC Biologics Appoints Boulder Site GM

      AGC Biologics Appoints Boulder Site GM

      David Stewart to oversee the startup, strategic development and operational excellence in large-scale biologics production at the Boulder, CO site.
      Kristin Brooks 01.22.21


    • Breaking News | Drug Development | Drug Discovery | Industry News
      Lilly Completes $1B Acquisition of Prevail

      Lilly Completes $1B Acquisition of Prevail

      Adds new modality for drug discovery and development and creates a gene therapy program with neuroscience assets.
      Kristin Brooks 01.22.21

    • Breaking News | Drug Development | Industry News | Information Technology | Regulatory Affairs
      Top BioPharma Form Accumulus Synergy

      Top BioPharma Form Accumulus Synergy

      Aims to develop a cloud-based Global Data Sharing Platform to facilitate data and information sharing between industry and health authorities worldwide.
      Kristin Brooks 01.22.21

    • Breaking News | cGMP Manufacture | Industry News
      CONTINUUS Awarded $69.3M DoD Grant

      CONTINUUS Awarded $69.3M DoD Grant

      Will enable construction of the country's first GMP facility for end-to-end, ICM-driven production of small-molecule drugs in Woburn, MA.
      Kristin Brooks 01.22.21


    • Biologics, Proteins, Vaccines | Breaking News | Drug Development | Industry News
      AbbVie Licenses ProBioGen’s GlymaxX Technology

      AbbVie Licenses ProBioGen’s GlymaxX Technology

      Will apply GlymaxX technology to boost the antibody-dependent cell-mediated cytotoxicity (ADCC).
      Kristin Brooks 01.22.21

    • Breaking News | Facilities | Industry News | Logistics | Packaging & Tracking
      WDSrx Expands Warehouse Network

      WDSrx Expands Warehouse Network

      Pharma logistics company creates national network with expansion to Reno, NV.
      Tim Wright, Editor, Contract Pharma 01.21.21

    • Aseptic Processing | Breaking News | Clinical Trial Materials | Collaborations & Alliances | Fill/Finish | Industry News
      Piramal Inks Clinical Supply Deal with Theratechnologies

      Piramal Inks Clinical Supply Deal with Theratechnologies

      CDMO to provide sterile fill/finish drug product formulation and manufacturing from its Lexington, KY facility.
      Tim Wright, Editor, Contract Pharma 01.21.21


    • Breaking News | cGMP Manufacture | Collaborations & Alliances | Facilities | Industry News
      Recipharm Signs Manufacturing Deal with Enzymatica

      Recipharm Signs Manufacturing Deal with Enzymatica

      Agreement will involve an additional Recipharm production site in Pianezza, Italy.
      Tim Wright, Editor, Contract Pharma 01.21.21

    • Bio News | Bioanalytical Services | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News
      CDMO Northway Biotech Expands in U.S.

      CDMO Northway Biotech Expands in U.S.

      Opens new biopharmaceutical manufacturing site in greater Boston area.
      Tim Wright, Editor, Contract Pharma 01.21.21

    • Breaking News | Industry News | Information Technology | Validation
      Global Biosciences Co. Selects ValGenesis VLMS

      Global Biosciences Co. Selects ValGenesis VLMS

      Will digitize the validation service activities for efficient and faster access to validated and safer products across 40 countries.
      Contract Pharma Staff 01.20.21

    Trending
    • Integrated Continuous Manufacturing ICM
    • Humanigen, Emergent Enter Covid-19 Partnership
    • Samsung Bioepis Opens New Headquarters
    • CDMO Northway Biotech Expands In U.S.
    • CONTINUUS Awarded $69.3M DoD Grant
    Breaking News
    • Civica to Build an Essential Medicines Manufacturing Facility in Virginia
    • Humanigen, Emergent Enter Covid-19 Partnership
    • Samsung Bioepis Opens New Headquarters
    • Pfizer, BioNTech Enter Vax Pact with COVAX
    • FDA Approves Janssen’s CABENUVA
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Modeling Process Safety Workflows in Pharmaceutical Manufacturing Scale-Up
    • Ensuring Quality During the Transfer and Scale Up of Rx Drugs
    • Inspecting the Unexpected
    • Cold Chain Trends
    • Catering for the Complex
    • Biopharma Contract Manufacturing: Robust Growth Ahead
    • DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    • The Single-Use Mixing Landscape: Evaluating Your Options
    • Self-Medication: Flexibility for Patients and Drug Manufacturers
    • Decentralized Trials Fuel AI Revolution in Clinical Research
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Clinical Evidence Suggests Potential Oral Benefits for Curcumin Extract
    Oleic Acid Possibly Implicated in MS Pathology
    NIH Study Compares Low-Fat, Plant-Based to Low-Carb, Animal-Based Diet
    Coatings World

    Latest Breaking News From Coatings World

    Vink Chemicals Offers parmetol PSG
    In Memoriam: CIN’s Honorary Chairman António Serrenho
    OQ Chemicals Announces Sales Control for US Oxo Intermediates
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Alleviant's Transcatheter Tech Obtains Breakthrough Status
    Signia Appoints New President
    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia
    Humanigen, Emergent Enter Covid-19 Partnership
    Samsung Bioepis Opens New Headquarters
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Aura Introduces Customizable Hair Care
    Corpack Creates Custom Packaging for Marlies Möller Hair Care Line
    Fitglow Beauty Wins Makeup Category at Annual Dirty Thinker’s Choice Awards
    Happi

    Latest Breaking News From Happi

    Some Good News at Inter Parfums
    Professional Beauty Association Names New Executive Director
    Curcumin's Role in Oral Care
    Ink World

    Latest Breaking News From Ink World

    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    UPM Raflatac unveils new lintless labeling product
    VPF launches deep-freeze adhesive
    ProMach strengthens flexible packaging business
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    osteolabs Closes Second Financing Round of Nearly 1.6 Million Euros
    First Patient Implanted With NEXXT MATRIXX SA Cervical Turn-Lock System
    Cretex Companies CEO Steps Down
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    Imec Technology Taking Off to Space
    North American Semiconductor Equipment Industry Posts December 2020 Billings

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login