Asphalion
✕
  • Home
  • About us
    • Mission, Vision, Values
    • Management and Directors
  • Services
    • Regulatory Strategy and Scientific Advice during Development
    • Medical and Scientific Writing
    • Horizon Europe Programme | Global Regulatory Partner​
    • Global Regulatory Submissions
    • eCTD and eSubmissions
    • ISO IDMP, Data Governance Services & RIM
    • Local Support and Regulatory Affairs Service Provider in Spain
    • Local Support in the UK – BREXIT
    • Medicinal Product Life-Cycle Management Outsourcing​
    • Pharmacovigilance and Drug Safety Services
    • CMC Regulatory Solutions
    • Medical Device Regulatory Services in EU and USA
    • Advanced Therapy Medicinal Products (ATMPs) & Biologics
  • Careers
    • Job Opportunities
    • Culture & values
    • Send us your CV
    • Life at Asphalion
  • News & Events
    • News
    • Events
  • Blog
  • Contact us

CMC Regulatory Solutions

icono-medical-writing

Specialized Standalone or Integrated CMC Regulatory Solutions

The term pharmaceutical CMC stands for chemistry, manufacturing and controls, and is a fundamental requirement of any pharmaceutical application to health regulatory agencies.​

EU & US CMC Experts​

At Asphalion, we have a team of CMC experts with sound knowledge and experience in a wide range of pharmaceutical forms and types of products:

  • Oral, injectable (including freeze-dried) and inhaled solid dosage forms
  • Topic, oral, injectable and inhaled liquid dosage forms
  • Topic, oral, injectable and inhaled semisolid dosage forms

We can either provide you a full integrated support (from lab to market) or a tailored support as per you specific needs, at any stage of development or during post-approval lifecycle of Human Medicinal Products:

  • Innovative (chemical and biological)
  • Generics
  • Biosimilars
  • EU Hybrids / US 505b2
  • Well-established use
  • Herbal

Our EU & US CMC experts can actively collaborate with you on the following regulatory solutions:​

Pharmaceutical Development​

  • Strategic development and Roadmaps – Integrated with Non-clinical & Clinical development
  • Gap analysis at every stage of drug development
  • Implementing and managing Quality by Design
  • EU IMPD & US IND(A) – writing, review and/or updates
  • Dossier writing, review and/or update – EU to US or US to EU
  • Due-diligence of in-licensed dossiers
  • Expert Reports
  • Ad-hoc regulatory strategy

Registrations / Applications​

  • CTD Mod. 2 and 3 writing, review and/or updates for the EU and US, including:
    • EU ASMF and US/RoW DMF.
    • Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)
    • EU MAA (CP, DCP, MRP, NP)
    • US IND(A), ANDA and NDA (505b1 and 505b2)
  • Dossier gap analysis (Mod. 2.3 and Mod. 3.2.S, 3.2.P and 3.2.R)
  • Due-diligence of in-licensing dossiers
  • Expert support on responses to Deficiency Letters
  • Expert Reports

Maintenance / Lifecycle Management​

  • CMC regulatory strategy
  • CMC Regulatory compliance gap analysis
  • Updating dossier sections – strategy, writing and review.
  • Variations – strategy, writing, review and/or update of dossier
  • Expert support on responses to Deficiency Letters
  • CMC Expert Reports (including updates)
  • Dossier consolidation of legacy dossiers (Mod. 2.3 and 3) towards eCTD publishing
  • Ad-hoc regulatory strategy

 

Do you need support or more information about the services? Contact us!




    I want to receive news and communications from Asphalion. yesno


    RELATED NEWS AND EVENTS

    Kick-off meeting| #SINPAIN project

    RBDCOV | HIPRA’s Covid-19 vaccine

    Kick-off | #SINPAIN project

    Tumor-LN-oC | 12-month follow-up meeting

    Did you know that?

    • Regulatory Strategy and Scientific Advice during Development
    • Medical and Scientific Writing
    • Horizon Europe Programme | Global Regulatory Partner​
    • Global Regulatory Submissions
    • eCTD and eSubmissions
    • ISO IDMP, Data Governance Services & RIM
    • Local Support and Regulatory Affairs Service Provider in Spain
    • Local Support in the UK – BREXIT
    • Medicinal Product Life-Cycle Management Outsourcing​
    • Pharmacovigilance and Drug Safety Services
    • CMC Regulatory Solutions
    • Medical Device Regulatory Services in EU and USA
    • Advanced Therapy Medicinal Products (ATMPs) & Biologics

    ASPHALION S.L.

    HQ – Barcelona
    info@asphalion.com
    +34 93 238 5945

    Munich Office
    munich@asphalion.com
    +49 (0)89 039 280

    Madrid Office
    madrid@asphalion.com
    +34 910 483 817

    London Office

    london@asphalion.com

    MEMBERSHIP

    CERTIFICATIONS

    ISO Certificate


     

     

    Seal of Innovative SME

    © All rights reserved - Legal disclaimer - Privacy policy -  Cookies Policy -  Quality Policy
    We use first party and third party cookies and for analytical and marketing purposes, as well as to share content on social media. Check our Cookies Policy for more information or click the below buttons as it corresponds.
    Accept all and continue navigating
    Configure or reject cookies
    Cookie Box Settings
    Cookie Box Settings

    Privacy settings

    Decide which cookies you want to allow.You can change these settings at any time. However, this can result in some functions no longer being available. For information on deleting the cookies, please consult your browser’s help function.Learn more about the cookies we use.

    With the slider, you can enable or disable different types of cookies:

    • Block all
    • Essential
    • Functionality
    • Analytics
    • Advertising

    This website will:

    • Essential: Remember your cookie permission setting
    • Essential: Allow session cookies
    • Essential: Gather information you input into a contact forms, newsletter and other forms across all pages
    • Essential: Keep track of what you input in a shopping cart
    • Essential: Authenticate that you are logged into your user account
    • Essential: Remember language version you selected

    This website won't:

    • Remember your login details
    • Functionality: Remember social media settings
    • Functionality: Remember selected region and country
    • Analytics: Keep track of your visited pages and interaction taken
    • Analytics: Keep track about your location and region based on your IP number
    • Analytics: Keep track of the time spent on each page
    • Analytics: Increase the data quality of the statistics functions
    • Advertising: Tailor information and advertising to your interests based on e.g. the content you have visited before. (Currently we do not use targeting or targeting cookies.
    • Advertising: Gather personally identifiable information such as name and location

    This website will:

    • Essential: Remember your cookie permission setting
    • Essential: Allow session cookies
    • Essential: Gather information you input into a contact forms, newsletter and other forms across all pages
    • Essential: Keep track of what you input in a shopping cart
    • Essential: Authenticate that you are logged into your user account
    • Essential: Remember language version you selected
    • Functionality: Remember social media settings
    • Functionality: Remember selected region and country

    This website won't:

    • Remember your login details
    • Analytics: Keep track of your visited pages and interaction taken
    • Analytics: Keep track about your location and region based on your IP number
    • Analytics: Keep track of the time spent on each page
    • Analytics: Increase the data quality of the statistics functions
    • Advertising: Tailor information and advertising to your interests based on e.g. the content you have visited before. (Currently we do not use targeting or targeting cookies.
    • Advertising: Gather personally identifiable information such as name and location

    This website will:

    • Essential: Remember your cookie permission setting
    • Essential: Allow session cookies
    • Essential: Gather information you input into a contact forms, newsletter and other forms across all pages
    • Essential: Keep track of what you input in a shopping cart
    • Essential: Authenticate that you are logged into your user account
    • Essential: Remember language version you selected
    • Functionality: Remember social media settingsl Functionality: Remember selected region and country
    • Analytics: Keep track of your visited pages and interaction taken
    • Analytics: Keep track about your location and region based on your IP number
    • Analytics: Keep track of the time spent on each page
    • Analytics: Increase the data quality of the statistics functions

    This website won't:

    • Remember your login details
    • Advertising: Use information for tailored advertising with third parties
    • Advertising: Allow you to connect to social sites
    • Advertising: Identify device you are using
    • Advertising: Gather personally identifiable information such as name and location

    This website will:

    • Essential: Remember your cookie permission setting
    • Essential: Allow session cookies
    • Essential: Gather information you input into a contact forms, newsletter and other forms across all pages
    • Essential: Keep track of what you input in a shopping cart
    • Essential: Authenticate that you are logged into your user account
    • Essential: Remember language version you selected
    • Functionality: Remember social media settingsl Functionality: Remember selected region and country
    • Analytics: Keep track of your visited pages and interaction taken
    • Analytics: Keep track about your location and region based on your IP number
    • Analytics: Keep track of the time spent on each page
    • Analytics: Increase the data quality of the statistics functions
    • Advertising: Use information for tailored advertising with third parties
    • Advertising: Allow you to connect to social sitesl Advertising: Identify device you are using
    • Advertising: Gather personally identifiable information such as name and location

    This website won't:

    • Remember your login details
    Save & Close