Implementation-ready Standard Operating Procedures for biotech and pharma laboratories where documentation gaps create operational risk and inspection exposure.
Our SOPs bridge the critical transition from research protocols to IND-enabling documentation. We structure documentation that meets GLP standards while remaining practical for operational teams, ensuring audit readiness without operational burden.
SOP development covers IHC assay protocols, histology workflows, quality control procedures, digital pathology operations, equipment operation and maintenance, and regulatory documentation. We develop SOPs informed by FDA, CLIA, CAP, and ISO guidance, structured for operational consistency and inspection readiness.
What's included: SOP drafting, review cycles, formatting to your organizational standards, version control setup, and training framework. What's not included: Laboratory certification, regulatory approval, or ongoing operational management.
Our Tissue Management and Histology & IHC consulting services provide the strategic foundation that informs these SOPs.
We observe your current processes and interview key personnel to understand existing workflows
We create custom SOPs tailored to your specific equipment, tissue types, and operational constraints
Pathology experts validate technical accuracy and regulatory alignment of each SOP
We provide training frameworks and QC checkpoints to ensure successful adoption
This is an advisory and consulting service. PathologyEdge does not certify, accredit, or approve laboratories. We do not operate as a clinical laboratory or provide regulatory approval services.
SOPs are delivered as audit-ready drafts intended to support internal decision-making and operational consistency. Our documentation is informed by FDA, CLIA, CAP, and ISO guidance, structured to support inspection preparedness. Final approval and implementation remain your organization's responsibility.
We review your study goals, available tissues, existing protocols, and constraints. This initial assessment identifies gaps, risks, and optimization opportunities.
We evaluate your current workflows, sample handling, assay performance, or pathology data quality. This identifies failure modes and decision points.
We deliver concrete outputs—protocols, SOPs, review reports, or workflow frameworks—with implementation guidance and follow-up support as needed.
Ideal for specific deliverables like SOP development, gap analyses, or protocol optimization.
We align our consulting with your drug development milestones (e.g., Pre-IND, Phase I readout).
Long-term, on-call pathology judgment for teams requiring consistent oversight across multiple programs.
Consulting engagements are tailored to the complexity and regulatory stage of your program. Contact us for a bespoke proposal.