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Services

  • Supply Chain

    • Create drug supply strategies and timelines for pre-clinical studies, sponsored clinical trials and external partnerships in collaboration with internal teams.
    • Evaluate, select, and setup Contract Manufacturing Organizations (CMOs).
    • Develop, manage, and monitor DS, DP and IP forecasts and plan inventory accordingly ensuring appropriate supplies are ordered, maintained, and distributed to depots and clinical sites.
    • Oversee logistics for bulk drug shipments between global contract manufacturing and depot facilities, including managing customs import/export activities.
    • Create, review, and modify SOPs for clinical trials supply as well as create templates for use during clinical trials (pharmacy manuals, request forms, excursion forms, etc.).
    • Select, setup, and manage Interactive Response Technology (IRT) vendor(s).
    • Set up and manage global depot network.
    • Participate in the qualification and selection process (RFP) for new clinical supply vendors, including contract labeling vendors, depots, transport carriers, and IRT systems.

  • Packaging Engineering

    • Design primary, secondary, and tertiary packaging (configurations and materials) for parenteral (Liquid/lyo, vial/syringes), solid dose (capsules, tablets, oral powder and granules), cell and gene therapy and device products.
    • Design container-closure integrity testing plans and methods.
    • Execute packaging design qualification for performance during distribution (shipping simulation and thermal qualification). Provide person-in-lab oversight responsibilities.
    • Execute packaging process validation at CMO’s: equipment qualification (IQ/OQ), performance qualification (PQ).
    • Develop packaging usability studies (Child Resistant/Senior Friendly testing) and human factor studies.
    • Evaluate and select tamper evidence seals to support custody chain.
    • Develop and qualify passive and active temperature-controlled parcel and pallet size solutions (controlled room temperature CRT, refrigerated, frozen, deep frozen and ultracold).
    • Review and approve CMO’s packaging specs, SOP’s, MBR’s, etc.
    • Develop and qualify new packaging platforms to support clinical projects in pediatrics, parenteral and comparator by reverse engineering.
    • Packaging and labeling CMO oversight, including person-in-plant responsibilities.
    • Evaluate, select and document prefilled syringes platform based on patients’ needs.
    • Author shipping studies for parenteral configurations (vial, syringes, needle safety devices, pens).
    • Prepare container closure documents for regulatory filings at Ph1-Ph3 approval into commercialization.
    • Interface with vendors to develop alternate designs of packaging components and translate into actionable specifications and equipment compatibility testing via IQ, OQ and PQ.
    • Perform technical investigations to support closure of packaging deviations.
    • Recommend packaging development lab equipment and creating equipment operating procedures.

  • Device Development

    • Design, develop, qualify, and validate sterile packaging components, medical devices and combination products.
    • Create cost effective and environment friendly packaging for medical device.
    • Establish end to end device supply chain (including evaluation, audit, selection, and management of material suppliers and contract manufacturers).
    • Design and execute human factors and usability studies including early exploratory research, formative and summative studies per FDA and ISO/IEC standards.
    • Create protocols, test scripts and reports, and overseeing execution by third party providers and contract testing labs.
    • Perform transportation and aging testing including development of protocols and reports
    • Create and implement device development and operations strategies which include drug delivery platform identification, development, and optimization.
    • Screen, audit, and manage market and technology research firms, component/subsystem suppliers, contract manufacturers, and human factors engineering companies.
    • Oversee the development and validation of manufacturing processes, in-process control, and release testing at suppliers and contract manufacturers.
    • Support transition from vial to autoinjector using phase appropriate strategies
    • Evaluate break-loose and glide force behavior in prefilled syringes systems
    • Evaluate transition from glass to plastic container closures
    • Collaborate with CMO’s to perform packaging equipment validation (URS, FAT, Line Trials, Risk Assessment, IQ, OQ, PQ, SOP) for fill-finish and needle safety device (NSD) assembly.
    • Create labeling master batch record template for prefilled syringes (PFS) and NSD assembly work.

  • Labeling

    • Create, implement, and maintain of Drug Substance (DS), Drug Product (DP), and Investigational Product (IP) labeling strategies.
    • Coordinate with project teams to harmonize global drug supply labeling, including tracking required label updates and implementation according to regulatory timelines by geographic region.
    • Plan and manage labeling content design, review, and approval process for single-panel and booklet labels (English label texts to label proofs).
    • Ensure label design can maintain adhesion over time when stored at Controlled Room Temperature CRT, 2-8°C, ≤-20°C, ≤-60°C and ≤-180°C.
    • Design blinding techniques for comparators, co-dosing and when parenteral active and placebo show visual difference.
    • Perform technical evaluation and support GMP audits of label suppliers.
    • Support GMP labeling set up and documentation for new and rush projects at CMO’s
    • Coordinate and managed CMO labeling operations (open label, blinded, randomized)
    • Actively manage labeling projects to launch Phase 1 through Phase 3 clinical studies for an array of packaging systems that include, HDPE bottles various sizes and shapes, thermo-formed and cold-formed blister packs, glass and plastic vials, syringes, pouches, stick packs, cartons, etc.