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
    • Sustainability
    • 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 > CMC Services

CMC Services

Chemistry, Manufacturing and Controls (CMC)

CMC strategy and documentation plays an important role from early development to authoring of the marketing authorization application dossier. It also extends to change control and maintenance throughout the product lifecycle. Moreover, CMC requirements are complex and different for chemicals, biologicals, biosimilars, herbals or homeopathics. PharmaLex guides you to the best CMC approach for your products in line with health authority requirements and helps you to stay CMC compliant with sustainable processes.

Our CMC services include:

  • CMC content creation, compilation and maintenance support
  • CMC development biopharmaceuticals
  • CMC compliance

Want to find out more?

PharmaLex. Confidence beyond compliance.

Contact us for more information

CMC content creation, compilation and maintenance support

Our Chemistry, Manufacturing and Controls (CMC) team can provide you with regulatory strategy advice, scientific/technical writing and quality variation/amendment/supplement submission management on a global basis. We cover all CMC regulatory tasks from early development to authoring of the marketing authorization application dossier and beyond. We can give you regulatory guidance in dossier format, setting specifications, method development and validation documentation adapted to any type of medicinal product or drug substance/API and to any region worldwide. Whether it is a case of first-time submission, change control or maintenance throughout the product lifecycle, our multi-disciplinary team delivers CMC service that is aligned with the needs of your global submission management department, manufacturing sites and other stakeholders and that, of course, meets the latest Health Authority requirements.

Our services include:

  • Product scope includes human and veterinary medicinal products comprising all types of APIs (chemicals, biologicals, biosimilars, herbals and homeopathics)
  • Strategic consultancy during pharmaceutical development and lifecycle management
  • Regulatory CMC intelligence and data management
  • CMC scientific and technical writing
  • Compilation of quality dossiers (ICH and non-ICH)
    • CTD modules 3 and 2.3
    • IMPD, IND
    • ASMF / DMF, CEP
    • Normative document
  • CMC maintenance support: change control and quality variations
  • GxP services (GMP, GACP, GDP) including audits

CMC development biopharmaceuticals

Biopharmaceuticals are an unprecedented success story. Due to their outstanding efficacy and safety and their high potential to address unmet medical needs, biopharmaceuticals are by far the fastest-growing part of the industry and are already making up 20 percent of the global pharma market.

But the effort and amount of technological skills required for the development and production of these complex molecules are both challenging and evolving rapidly, and so are the associated expectations of the regulators. Therefore, it is essential to account for regulatory requirements early on in development and to carve out the most efficient path to approval to ensure commercial success.

Based on a broad global project experience, we at PharmaLex recommend an integrated solution combining our scientific, technological and regulatory expertise to meet your specific support needs, both for specific aspects or for the complete development process.

The product types we support include:

  • Recombinant proteins (e.g. mAbs (and derivatives), hormones, enzymes, fusion proteins)
  • Tissue, cell and gene therapy products / ATMPs
  • Biosimilars
  • (Non-recombinant) biologicals isolated from living sources
  • Peptides
  • Antibody drug conjugates (ADC)
  • Vaccines (recombinant proteins, live attenuates and recombinant vector vaccines)

Our services include:

  • Development and regulatory strategy considering regional requirements (e.g. US, EU, Canada, Japan, Emerging Markets)
  • Gap analysis / Due diligence
  • Scientific and technical writing and compilation of regulatory documents
  • Scientific advice and other Health Agency meetings
  • Risk assessment
  • Preparation of Target Product Profile (TPP)
  • Comparability exercises
  • General ‘troubleshooting’, including investigations and root cause analysis and support for CAPA
  • Deviation and change control preparation / review
  • Method / process validation
  • Process characterization
  • Project management

CMC Compliance

Chemistry Manufacturing and Controls (CMC) compliance is an important component in the lifecycle of a medicinal product, but is one that is continually challenged by many factors, including Merger and Acquisition (M&A) programs, increasingly complicated networks of internal and external manufacturing sites and insufficiently robust internal processes within an organization to manage complexity and cross-functional interfaces.

These factors often lead to compliance issues, which may have serious consequences from a delay in product approval requiring corrective actions up to product recalls and the loss of marketing authorizations. It is clear that the impact of non-compliances identified through Health Authority inspections can be extremely costly and can irrevocably damage a company’s reputation.

A strong partnership is required between the Regulatory and Quality functions with the necessary inputs to support the implementation of transformed systems and processes within an organization, which can ultimately provide a sustained CMC compliance outcome for a business.

Our team of CMC and Quality experts will help you make your compliance proactive and in line with Health Agencies’ requirements, supporting the uninterrupted supply of medicines to patients. Besides broad experience, we bring a standardized approach and ready-to-use templates for compliance gap analysis and remediation to the table. And we can provide the needed resources to manage such projects even under high time constraints.

Our services include:

  • CMC Due diligence (e.g. in-licensing activities) / Gap analysis
  • Product / patient impact assessment
  • Development and implementation of risk-based gap remediation plan
  • Root Cause Analysis of gaps in CMC information
  • Preparation for regulatory health authority inspection (incl. CAPA-management)
  • Optimization of the supply chain
25+ years of experience in global regulatory maintenance support and CMC
125+ CMC experts worldwide
750+ quality overall summary expert reports prepared
Proven track record with 7500 successfully completed projects

Related News

Is quality documentation an asset or a burden in regulatory affairs?
Is quality documentation an asset or a burden in regulatory affairs?
6th April 2022
How Advanced Therapeutic Mergers & Acquisitions Impact Negotiations and Integration
How Advanced Therapeutic Mergers & Acquisitions Impact Negotiations and Integration
26th February 2022
PharmaLex merger with MAP Group expands integrated market access expertise
PharmaLex merger with MAP Group expands integrated market access expertise
18th January 2022

Related Resources

Fact Flyers

  • Regulatory Compliance - CMC Implementation
  • Biopharmaceuticals CMC
  • Chemistry, Manufacturing and Control (CMC)

Case Studies

  • Regulatory CMC Compliance reduced risk
  • End of Phase-2 meeting
  • Consultancy and eCTD submission support for master files
  • Global CMC responsibility during portfolio integration
  • Lifecycle management for drug products
  • Regulatory CMC compliance reduced workload by 20-25%
  • Due diligence for medicinal product documentation

White Papers

  • Together Beyond COVID-19 - A Look at the Future
  • The Challenges of Achieving and Maintaining CMC Compliance
  • Differing CMC requirements: US and EU

Webinars

  • Introduction to Bayesian Methodologies in CMC
  • Biotech Drug Development Challenges and Case Studies (CMC)
  • Achieving and maintaining REG CMC Compliance

Related Services

  • Biopharmaceuticals
  • Global End-to-End Outsourcing
  • GxP Services
  • INTEGRATED PRODUCT DEVELOPMENT (IPD)
  • Mergers and Acquisitions (M&A) Transfers

What our clients say

I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.

Lorraine Henry
Compliance Lead, Qualified Person, Amneal Ireland Limited

Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.

Leading European Specialist Pharma Company
Head of Medical Writing and Publications
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
pharmalexglobal PharmaLex @pharmalexglobal ·
11h

📢  Listen to our expert Clare Huntington in our latest podcast, How the #MDR has changed the roles and responsibilities of “economic operators” to learn more.

👉 https://lnkd.in/d5GgSTHb

#medicaldeviceregulation

COVID-19 NEWSLETTER SIGN UP

SIGN UP NOW

WHAT OUR CLIENTS SAY
  • They are available when we need to talk to them despite any time zone differentials

    Japan based medium sized company
    Manager
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