TwitterLinkedin

Contact Us

  • Biopharma Excellence
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Current Opportunities
  • Training
Top Bar
Search
PharmaLex Logo
MENUMENU
  • PharmaLex Logo
  • PharmaLex Logo
  • About UsAbout Us
    • About Us
    • Management Team
    • Corporate Social Responsibility
    • What Our Clients Say About Us
  • Our Services
    • Discovery / Non-clinical
          • Go to Discovery / Non-clinical section >>

          • Strategy and Consulting

            • Integrated Product Development
            • Market Access
            • Scientific Advice
            • Statistics and Data Sciences
            • Toxicology Services
    • Clinical Development
          • Go to Clinical Development section >>

          • Strategy and Consulting

            • Clinical Program Development
            • Scientific Advice
            • Statistics and Data Sciences
          • Regulatory Affairs

            • Clinical Trial Applications
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Regulatory Operations
          • Pharmacovigilance

            • Clinical Trial Safety Support
            • Pharmacovigilance Consulting
          • Quality

            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
            • Tech Transfer / Scale-up
    • Authorization / Approval
          • Go to Authorization / Approval section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Regulatory Operations
            • Scientific, Regulatory and Technical Writing
            • Statistics and Data Sciences
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • Pharmacovigilance Consulting
          • Quality

            • Commercialization Readiness
            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • PAI Readiness
    • Post-approval / Maintenance
          • Go to Post-approval / Maintenance section >>

          • Strategy and Consulting

            • Market Access
          • Regulatory Affairs

            • CMC Services
            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Health Authority / Agency Interaction
            • Marketing and Labeling Activities
            • Mergers and Acquisitions (M&A) Transfers
            • Regulatory Operations
            • Toxicology Services
          • Pharmacovigilance

            • EU QPPV / National QPPV
            • ICSR (Individual Safety Case Report) Management
            • Literature Monitoring & Screening
            • Pharmacovigilance Quality & Compliance
            • Signal Management
          • Quality

            • Commissioning, Qualification, and Validation (CQV)
            • GxP Services
            • Interim / Contract QA
            • Quality Management Systems
          • Medical Affairs

            • Healthcare Compliance and Medical Approval
    • Program Management
          • Go to Program Management section >>

          • Program Management

            • Global End-to-End Outsourcing
            • Global Procedure Management
            • Integrated Product Development
            • Mergers and Acquisitions (M&A) Transfers
    • Featured Expertise
          • Industry Expertise

            • Biopharmaceuticals
            • MedTech Services
          • Service Expertise

            • ATMP / Cell and Gene Therapy
            • COVID-19 Support
            • GxP Services
            • Market Access
            • Pharmacovigilance Consulting
            • Post-Brexit Regulatory Support
            • Statistics and Data Sciences
            • SMARTPHLEX - technology-enabled services
  • Global ReachGlobal Reach
  • Contact usContact us
  • News & Events
    • Industry News Articles
    • Press Releases
    • Webinars
    • Events
    • Blog
    • Podcasts
  • Resource Library
    • Thought Leadership
    • Fact Flyers
    • Case Studies
    • White Papers
    • Webinars
    • Infographics
    • Video & Animation
  • Careers
    • Life at PharmaLex
    • Career Opportunities
  • Training
Home > Our Services > MAA / NDA Submissions

MAA / NDA Submissions

Developing novel medicines on a global scale

Public health emergencies of international concern such as COVID-19 clearly show the significance of fast and efficient processes to develop novel medicines on a global scale. What we at PharmaLex have observed over the past few years is an increasing amount of pharmaceutical businesses aiming to obtain marketing authorization in both the EU and US jurisdictions (or in some cases even additional ones such as China). By obtaining a more or less simultaneous authorization, they benefit from synergies and a remarkably reduced time-to-market.

The economic success of pharmaceutical companies heavily depends on their ability to make the right decisions regarding their marketing strategy and how they transform their vision into efficient operations. Once a promising drug candidate has entered the late phase of development and a global business strategy evolves, it is time to start thinking about the regulatory applications: the planning, preparation and submission of the application dossier in all targeted jurisdictions.

Want to find out more?

PharmaLex. Confidence beyond compliance.

Contact us for more information

Smart Submission Planning: Getting the Best out of your Submissions

From a business perspective New Drug Applications (NDAs), Biologics License Applications (BLAs) and Marketing Authorization Applications (MAAs) are best prepared using a maximum of synergies, which requires smart and careful planning well ahead of starting the actual work. Storyboarding exercises may commence during the clinical phase and still continue to be a central topic throughout the preparation of a compelling dossier, which is both globally consistent and locally adapted in a finely balanced way.

An aspect easily neglected until the eleventh hour is the compilation, e-readiness, and publishing of a fully compliant eCTD through the appropriate electronic gateways and platforms. Underestimation of these final steps in a submission often leads to missing internal or external deadlines associated with delays in market access.

Our Experience is Key to your Success

Based on our experience with simultaneous submissions over the past decades, PharmaLex has implemented a process that allows our clients to take full advantage of the synergies of parallel submissions while minimizing the risks of non-compliance or delays. The cornerstones of our approach are an expert team with clearly defined and client-tailored roles and responsibilities under a strong global program leadership possessing outstanding scientific as well as local regulatory expertise including New Chemical Entities (NCE), New Biological Entities (NBE), Generics, Biosimilars, Advanced Therapy Medicinal Products (ATMP) and Medical Devices in all major Therapeutic Areas.

With a proven track record of successful applications of a great variety of pharmaceutical development projects PharmaLex is able to provide tailored solutions for the above scenarios, utilizing its concept of “global reach and local presence”. Headquartered in Europe and having a strong team based in the US (and many other countries and regions of interest), we are ideally positioned to assemble a powerful international team of experts under the leadership of an experienced Regulatory Program Leader to navigate you through the intricacies of a complex undertaking such as a parallel submission in two or more jurisdictions.

PharmaLex enables you to get your product to all of your desired markets fast, in a cost-efficient manor whilst minimizing the risks of non-compliance.

About PharmaLex

0+

Regulatory Experts

0+

Registration Procedures (DCP, MRP, CP, NDA and ANDA)

0+

Former Regulatory Authority Employees on Staff

0

Offices Worldwide

Related News

PharmaLex broadens market access and HEOR reach
PharmaLex broadens market access and HEOR reach
4th June 2021
BREXIT: Pharmacovigilance - Key changes
BREXIT: Pharmacovigilance - Key changes
3rd September 2020
First approved application for BioBag® medicinal larvae
First approved application for BioBag® medicinal larvae
25th August 2020

Related Resources

Fact Flyers

  • FDA meetings and health authority interactions
  • Regulatory Submissions for Tobacco and Vape Products
  • Regulatory Affairs Application Services

Case Studies

  • Post-regulatory support to an EMA clinical submission
  • MA applications to EMA and FDA in parallel
  • Consultancy and eCTD submission support for master files
  • Flexible eCTD publishing support
  • eCTD submissions for global DMF portfolio
  • Regulatory publishing support on request
  • Multi-country Phase III clinical trial support
  • Preparation, submission and coordination of a CP for PUMA

White Papers

  • Navigating the regulatory submission process for a class III medical device with ancillary medicine

Webinars

  • Unlocking BLA, NDA, IND Submissions Key considerations and LORENZ docuBridge training
  • New legal requirements for electronic submissions in the EEU
  • What you need to know to submit INDs in eCTD format

Related Services

  • ANDA Withdrawals
  • Global End-to-End Outsourcing
  • Global Procedure Management
  • Health Authority / Agency Interaction
  • Healthcare Compliance and Medical Approval
  • INTEGRATED PRODUCT DEVELOPMENT (IPD)
  • Nitrosamines
  • Tobacco and Vape Products

What our clients say

During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.

Large Pharma, Germany
VP Regulatory Affairs

I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.

Richard Blackwell
Medical Team Leader, Multi Tumor Franchise Roche Products Ltd
Biopharma Excellence Website Image

PharmaLex Brings You Biopharma Excellence

Biopharma Excellence is a fusion of three scientific powerhouses, PharmaLex, ERA Consulting and Biopharma Excellence – all under the PharmaLex brand. This global team of scientific, regulatory and commercial professionals provide strategic product development and proactive regulatory services to developers of biopharmaceuticals, cell and gene therapies, monoclonal antibodies (MABs), vaccines and biosimilars.

Visit Website
USEFUL LINKS
  • Home
  • Contact us
  • Imprint
  • Data Protection
  • Terms and Conditions
RECENT TWEETS
PharmaLexGLOBALPharmaLex@PharmaLexGLOBAL·
24 Jun

Milena Shuytsova-Mircheva and Lisa Pascoe latest blog here https://www.pharmalex.com/sponsors-gear-up-for-a-smoother-process-with-ctis-but-must-first-overcome-key-hurdles/ discusses the benefit of the Clinical Trial Information System (CTIS).

💡 Interested in CTIS? Take the Phlexglobal survey to evaluate your preparation https://www.phlexglobal.com/ctis-survey

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected

    Small US Biopharmaceutical Company
    Sr Director Regulatory Affairs CMC
PharmaLex
©2022 PharmaLex GmbH. All rights reserved.

ISO9001:2015 LogoEnergie Audit LogoSGS Logo

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from @pharmalex.com. Should you receive an email and are unsure as to its validity, please report it to contact@pharmalex.com.

Many thanks for your understanding.

The PharmaLex Team

    Please DO NOT send us event/conference information.
    We will not respond and these will be deleted immediately.






    Select your state:

    .
    If you do not wish to receive any communication from us, you may unsubscribe at any time.

    #AskTheExpert #TogetherBEYONDCOVID19





      Select your state:

      .
      You can unsubscribe at any time at data.protection@pharmalex.com

      If you do not wish to receive any communication from us, you can unsubscribe at any time at. Click here to view our Privacy Policy.

      #TogetherBEYONDCOVID19

      We closely monitor developments and updates surrounding the current outbreak of Coronavirus Disease 2019 (COVID-19) from official sources including the World Health Organisation and are following the guidance and direction of the governments and the local authorities. We are taking this situation very seriously and our number one priority is the safety and business continuity for our customers and colleagues. As ever, we will do everything we can to ensure that services are delivered within the required time and the trusted quality PharmaLex is known for