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What We Offer

Analytical & Technical Consulting – Method development, validation, and problem solving

Quality & Compliance Support – SOPs, documentation, inspections, and readiness

Laboratory Operations & Strategy – Workflow optimization, systems, and team support

  • Scope: Technical design, development, and pre‑validation of LC/MS, MSD, ELISA, bioanalytical methods (R&D only) for small molecule and biologics.

    Included capabilities:

    • Method development, sample‑prep design, chromatography/signal and parameter optimization

    • Sensitivity/selectivity optimization, stability‑indicating method development, forced‑degradation R&D

    • Fit‑for‑purpose pre‑validation experiments, assay troubleshooting, robustness testing

    • Preparation of GLP‑ready validation protocols, SOP drafts, and method transfer packages

    Outcome: Robust, regulator‑ready method packages and R&D datasets clearly labeled non‑GLP; deliverables ready for formal GLP validation at an accredited lab.

  • Scope: GLP guidance, documentation, and audit preparation (we do not perform GLP runs).

    Included capabilities:

    • GLP gap analyses, SOP writing/updating, data integrity reviews and remediation plans

    • IQ/OQ/PQ planning and template generation; performance verification plans for GLP sites

    • Mock audits, inspection coaching, CAPA development, and regulatory submission support (method sections, Q&A)

    Outcome: Audit‑ready quality systems, GLP‑compliant documentation packages, and actionable remediation plans to enable accredited GLP execution by a performing lab.

  • Scope: Lab workflow, infrastructure, and informatics strategy for GLP readiness; in‑house work limited to R&D setup and testing.

    Included capabilities:

    • GLP workflow design, lab layout recommendations, equipment qualification planning (planning and R&D qualification)

    • LIMS selection guidance, method integration planning, and data workflow validation templates

    • Design of chain‑of‑custody, batch documentation, and operational SOPs; R&D staff training and dry‑runs

    Outcome: Validated operational plans, LIMS/informatics requirements, and trained teams ready to implement GLP processes at an accredited facility.Flexible, expert advice when you need it. Book hourly support across a range of topics—from planning to problem-solving. This focused consultation will help clarify your goals, map out next steps, and identify opportunities for growth.

  • Scope: Flexible execution models with in‑house R&D execution only; management/oversight of GLP execution by accredited labs.

    Included capabilities:

    • In‑house R&D execution: method dev, pre‑validation, stability R&D, and troubleshooting (non‑GLP)

    • Vendor/CRO selection, qualification, method transfer management, and technical oversight for GLP runs performed by partner labs

    • On‑site support at GLP facilities during transfer/first runs (we can attend and advise); rapid‑turnaround R&D development and retainer options

    Outcome: Deliverable paths that combine our R&D output with accredited GLP execution — sponsor receives regulator‑acceptable GLP data via partnered GLP lab while we provide methods, oversight, and decision‑ready documentation.