Manufacturing & Labelling Clinical Supplies

In the realm of drug product manufacturing for clinical supplies, I bring a wealth of experience and expertise to ensure strict adherence to Good Manufacturing Practice (GMP) quality standards and regulatory requirements. This commitment is paramount to guaranteeing the safety, efficacy, and suitability for use in clinical studies. My proficiency encompasses key manufacturing steps such as formulation development, raw material procurement, manufacturing, packaging, labeling, quality control testing, and quality release for use. Core competencies include the manufacture of tablets, capsules, liquids & creams, sterile manufacturing, and comparator blinding approaches.

Key Areas of Expertise:

Compliance: Navigating complex regulatory requirements to ensure adherence to applicable standards, minimizing the risk of regulatory issues or delays.

Efficiency: Leveraging knowledge of processes and dosage forms to optimize manufacturing processes, increasing productivity, reducing costs, and shortening production lead times.

Risk Mitigation: Proactively identifying and addressing potential risks and challenges to minimize errors, deviations, or disruptions in the supply chain.

Innovation: Implementing innovative approaches to manufacturing based on expertise in emerging technologies and best practices, enhancing product quality and efficiency.

Scalability: Expertise in scaling production to adapt quickly to changes in demand, whether scaling up for large clinical trials or scaling down for smaller studies, without compromising quality or compliance.

Customer Satisfaction: Consistently delivering high-quality clinical supplies on time and within budget to enhance customer satisfaction and ensure the smooth progression of clinical activities.

Packaging & Labelling Strategy:

Smart packaging configuration and design choices play a crucial role in ensuring the correct administration of the study drug. Proactively planning a robust strategy for packaging can optimize costs, minimize waste, and ensure an adequate supply throughout the study.

Examples of Strategies:

  • Kitting supplies into easy-to-remember dosing configurations.
  • Strategic text placement or use of color to prevent dispensing errors.
  • Use of tamper-evident materials to comply with child-resistant regulations.

Label design and text placement are fundamental in ensuring compliance with national regulations and facilitating easy dispensing for sites and patients. I collaborate with quality and regulatory functions to ensure label text meets protocol requirements, and translation occurs in a timely manner, covering multiple languages including European languages, Hebrew, and major languages used in APAC countries, English, Spanish, and French in North America.

Given the reliance on third-party vendors in manufacturing, packaging, and label production, I am well-versed in project management techniques to ensure efficient and effective execution, recently obtaining PMPĀ® Certification to showcase this competency.

Core Services

  • Forecasting & Planning

    Learn More
  • Interactive Response Technology (IRT)

    Learn More
  • Vendor Oversight

    Learn More
  • Distribution & Logistics

    Learn More
  • Inspection Readiness & TMF

    Learn More