NGT BioPharma Consultants

Chemistry, Manufacturing & Controls (CMC)

CMC are critical activities ensuring the quality, safety, and efficacy of drug substance and products through rigorous oversight of their composition, manufacturing processes, and regulatory compliance, enabling consistent production, scalability, and approval for clinical and commercial use.

NGT BioPharma Consultants’ Chemistry, Manufacturing & Controls (CMC) services supports both small molecules and biologics (e.g., mAbs, duobodies, proteins, cell/gene therapies, and other new modalities) for drug substance, drug product and analytical disciplines, recognizing that their relevance varies depending on a  project’s stage of development.

Our extensive expertise and capabilities span late-stage discovery through preclinical and clinical drug development, registration, commercialization, and life-cycle management. NGT’s CMC consultants collaborate seamlessly with other key drug development functions, including our Nonclinical, Clinical, Quality/Compliance, and Regulatory teams. The CMC (API, Drug Product & Analytical) services offered by NGT BioPharma Consultants encompass, but are not limited to, the areas outlined below:

Early-Stage Development

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Late-Stage Development

DIGITAL SERVICES EXPERTISE

Cloud based systems, highly connected labs (IOT), standardized and unified data models, product and process digital twins, and the use of artificial intelligence and machine learning offer significant opportunities to transform and accelerate R&D and manufacturing workflows. However, many functions are struggling to navigate these opportunities and move beyond lab digitization and automation.
 
The Digital Services is a key service area within NGT BioPharma Consultants that focuses on helping clients increase their digital capability.

OUR SERVICES INCLUDE:

  • STAFF AUGMENTATION
    • Enhancing internal digital intervention team capabilities through contracted subject matter experts who provide specific skill sets such as computer systems validation experts, business analysts, product managers, and Agile Scrum masters.
  • SOFTWARE DEVELOPMENT AND MARKETING CONSULTANCY
    • Bespoke advisory services to interpret industry challenges and translate into requirements and IT products or platform functionality.
    • Marketing support to position digital products with the right decision-makers.
  • DIGITAL STRATEGY CONSULTANCY
    • Benchmarking current digital capabilities against industry best in-class and highlighting gaps and opportunities.
    • Reviewing and critiquing existing digital strategies.
    • Facilitating the creation of a digital strategy.
    • Work-flow reinvention and disruption to exploit digital capabilities.

Talk to NGT BioPharma Consultants to learn how we can deliver a customized solution to address your project needs.

DIGITAL SERVICES EXPERTISE

Cloud based systems, highly connected labs (IOT), standardized and unified data models, product and process digital twins, and the use of artificial intelligence and machine learning offer significant opportunities to transform and accelerate R&D and manufacturing workflows. However, many functions are struggling to navigate these opportunities and move beyond lab digitization and automation.
 
The Digital Services is a key service area within NGT BioPharma Consultants that focuses on helping clients increase their digital capability.

OUR SERVICES INCLUDE:

  • STAFF AUGMENTATION
    • Enhancing internal digital intervention team capabilities through contracted subject matter experts who provide specific skill sets such as computer systems validation experts, business analysts, product managers, and Agile Scrum masters.
  • SOFTWARE DEVELOPMENT AND MARKETING CONSULTANCY
    • Bespoke advisory services to interpret industry challenges and translate into requirements and IT products or platform functionality.
    • Marketing support to position digital products with the right decision-makers.
  • DIGITAL STRATEGY CONSULTANCY
    • Benchmarking current digital capabilities against industry best in-class and highlighting gaps and opportunities.
    • Reviewing and critiquing existing digital strategies.
    • Facilitating the creation of a digital strategy.
    • Work-flow reinvention and disruption to exploit digital capabilities.

Talk to NGT BioPharma Consultants to learn how we can deliver a customized solution to address your project needs.

Working with Big Pharma Globally

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Get in touch

For additional information regarding NGTs CMC capabilities & expertise, please contact Mark Krook or our CEO Michael O'Brien via the contact information provided below. Alternatively, please fill out the form below and our team we will get back to you within 48 hours.

Mark A. Krook, PhD

Mark A. Krook, PhD

Small Molecule CMC and Early Drug Development

Michael K. O’Brien, PhD

Michael K. O’Brien, PhD

President & CEO

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