End to end product development

End to end product development

End to end product development services

At ND Global in Pharmaceuticals industry, we specialize in product development for highly regulated markets, including the United States, Europe, Canada, and Australia. Our commitment lies in delivering on-time promises, quality, and trust. As trusted experts, we are proud to offer comprehensive services that cover all the aspects of pharmaceutical development.

Our services include:

Formulation Development:

ND Global's seasoned experts specialize in transforming your formulation ideas into marketable products compliant with FDA and regulatory standards. Operating under Quality-by-Design principles, their extensive experience in formulation development, scaling, and commercialization ensures that your concepts are translated into successful dosage forms. Their proactive approach to regulatory guidance, problem-solving capabilities, and diverse expertise in various dosage forms make ND Global a valuable partner for navigating the complexities of product development and achieving market success.

  • Liquids
  • Oral Solids
  • Sterile Forms
  • Optic and Ophthalmic Preparations
  • Topical Products
  • Novel Delivery Systems

(CDMO) Contract Development and manufacturing operations:

ND Global plays a pivotal role as a Contract Development and Manufacturing Organization (CDMO) dedicated to the pharmaceutical sector. Our core mission revolves around delivering holistic services to clients, encompassing the entire spectrum from initial drug development stages to the final manufacturing process. With a strong commitment to quality and efficiency, we facilitate a seamless journey for our clients' products. Through our comprehensive approach, ND Global contributes significantly to the pharmaceutical industry by offering a reliable partner for the complete lifecycle of drug development and manufacture.

  • Tablets
  • Capsules
  • Sachets
  • Clinical Supplies

Analytical Development:

ND Global provides essential support in Analytical Development through our partnered laboratory specializing in this area. We excel in method development, validation, and transfer, as well as identification and quantification of contaminants, stability studies, and more. Our analytical approach adheres to Quality by Design (AQbD) principles, ensuring consistent, dependable services that extend from dossier filing and beyond.

Technology Transfer:

Our commitment to seamless technology transfer spans the entire product lifecycle. With a comprehensive strategy, we handle technology transfer documentation, scale-up batch manufacturing, analytical method transfer, and exhibit batch manufacturing. Our approach aligns with ICH Q8 to Q14 guidelines, ensuring a streamlined and effective technology transfer process.

Validation (Facilities, Utilities, Process, Equipment, Computer Systems):

Our services guarantee adherence to industry regulations and standards. Our expertise encompasses various crucial areas, including facility, utility, process, equipment, and computer system validation. This comprehensive validation approach ensures the reliability and compliance of your operations.

  • Facilities
  • Utilities
  • Process
  • Equipment
  • Cleaning validation
  • Computer Systems

Automation Engineering:

We offer automation engineering services to optimize manufacturing processes and ensure precision. Our expert’s handle:

  • Automation System Design
  • Implementation
  • Testing
  • Commissioning
  • Validation

Why Choose Us:

Our competitive advantage is rooted in providing IP and regulatory-compliant process proposals, leveraging Quality-By-Design (QbD) principles. We prioritize Quality Target Profiles (QTP), Critical Quality Attributes (CQA), and Risk Assessment (QRM) in our development process.

Our Design of Experiments (DOE) and patent non-infringing formulation strategies underscore our commitment to innovation, value creation, and project excellence.