Services

  • Quality Assurance Consulting

    We’ll lead the way or join the team.

    When a biopharmaceutical or medical device company needs a QA consultant, it’s usually for one of two reasons. Either they need someone who can provide high-level leadership and guidance in establishing the company’s QA practices from the ground up or they need someone who can step in to supplement existing staff during busy times. At Complya, we address both types of needs. Our roster of consultants ranges from strong mid-level talent to some of the highest skilled, senior-level talent in the industry. Our goal: match your needs with the right person for the job.

    • Our consultants’ expertise includes:
    • GXP Services
    • Quality System strategies – High level initial assessments and strategy for developing complete QA systems
    • Document Control systems (including EDMS rollout)
    • SOP generation
    • Investigations and Root Cause Analysis
    • Personnel training and cGMP Training
    • Vendor/supplier qualification program overhaul (Vendor Management)
    • Internal audits
    • Quality Metrics
    • Process improvement
    • Part 11 compliance/IT validation risk assessment
    • Disaster recovery strategy
    • cGMP Services
    • Vendor & Supplier cGMP Audits
    • Batch record review
    • Validation review (IQ/OQ/PQ, Cleaning Validation, Process Validation)
    • Material Quarantine/Release Programs
    • Stability program management and trending
    • Environmental Monitoring Programs
    • Material Review Board participation/support
    • CMO selection and management
    • CMO Oversight & Person-in-Plant Support
    • Pre-Approval Inspection (PAI) preparation services
    • ISO Certification preparation services
    • Qualified Person (QP) Audit preparation services
    • Clinical Compliance/GCP Services
    • QA Oversight of Clinical Data Management
    • Clinical investigator audits
    • CRO selection and management audits
    • Central clinical file audits
    • Clinical document review (Protocol, ICF, IB, CSR)
    • SOP Generation
    • IVRS Oversight
    • Clinical site selection, initiation, and monitoring visits
    • Medical Writing
    • Laboratory Compliance/GLP Services
    • Contract laboratory selection and management
    • Laboratory inspections and in-process audits
    • Protocol & report reviews
    • Quality System development and strategy for a GLP Program
    • Personnel training and GLP Training Programs

  • SOP generation

    SOP generation expertise that saves you time and money

    The FDA mandates that biopharmaceutical and medical device companies define and maintain written Standard Operating Procedures (SOPs) for the manufacture of their products. Failure to maintain comprehensive up-to-date SOPs could jeopardize product quality and patient safety, and result in costly regulatory action. At Complya, we offer consultants who understand FDA expectations, along with time- and money-saving strategies for developing SOPs from the ground up that satisfy those expectations. The SOPs that we generate will be sustainable and appropriate for your company's size and stage of development.

    • Typical SOP generation projects:
    • Document Control
    • Material Quarantine/Release Programs
    • Personnel Training Programs
    • Vendor/Supplier Qualification
    • Equipment/Facility SOPs
    • Batch Disposition
    • Deviation, Out-of-Specification Results, and CAPA
    • Change Control Program
    • Good Documentation Practices
    • Material Review Board

  • Regulatory Affairs

    The right experience for your regulatory affairs challenges

    Biopharmaceutical and medical device companies frequently encounter complex regulatory affairs challenges. Whether you need someone to represent your company to the FDA or deal with internal CMC or Clinical regulatory issues, Complya has the answer. Our regulatory consultants have a diverse set of skills and experience, ranging from high level strategy and senior regulatory management to day-to-day task coverage. We provide the CMC, Clinical, and Regulatory Operations services that are appropriate for your need.

    • Areas of regulatory specialization
    • Regulatory Strategies (Domestic and Global) – High level planning and strategic guidance
    • Preparation of Regulatory Filings – For US and international regulatory agencies in CTD or eCTD formats
    • Regulatory Operations and Project Management of Filings
    • Change Assessment & Filing – Tracking changes in manufacturing operations and reconciling with FDA (or international) requirements
    • Labeling Review – Regulatory review of clinical and commercial product labeling/packaging
    • Advertising & Promotional Material Review
    • Regulatory Agency Relations – Attending or hosting meetings with US, Canadian, European, Indian, Chinese, Japanese, and other regulatory authorities