Regulatory Compliance
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Enable.
Efficient. Delivery.
Manufacturing Systems Excellence for Regulated Industries
Regulatory Compliance
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Proven Track Record
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Rapid Deployment
FDA 21 CFR Part 11 & EU Annex 11
Trusted by Pharma Leaders
40-60% Faster Implementation
Bridging Manufacturing Operations and Technology
Lark & Stern Consulting Inc. specializes in manufacturing systems implementation for pharmaceutical, life sciences, and regulated industries. We don't just deploy technology—we ensure your digital transformation delivers measurable operational value.
Our Three-Tiered Approach:
Business → Process → Technology
Ensuring Organizational Alignment and Business Readiness
We begin by understanding your manufacturing requirements and regulatory constraints, translate these into optimized processes, implement validated technology solutions, and ensure your teams are prepared for successful adoption.
Whether implementing Electronic Batch Records, deploying Manufacturing Execution Systems, or integrating SAP manufacturing modules, we align technical capabilities with your production goals—ensuring compliance, quality, and operational excellence.
Our Solutions
We specialize in SAP-based manufacturing solutions for regulated industries, with deep expertise in Electronic Batch Records, Manufacturing Execution Systems, and validated system integration.
Electronic Batch Records (EBR)
Implementing SiMPL—a productized Electronic Batch Record accelerator built within SAP. This proven solution leverages your existing SAP infrastructure to deliver faster time-to-value than custom development.
Key Benefits:
- 50-70% faster batch review cycles
- 60-80% fewer documentation errors
- FDA/EMA compliant
Typical Timeline: 4-12 months
Ideal For: Pharmaceutical, biologics, cell & gene therapy, CMOs
Manufacturing Execution Systems (MES)
End-to-end MES implementation for pharmaceutical and regulated manufacturing environments. From initial requirements through validation and go-live support.
Our MES Expertise:
- Batch execution & scheduling
- Equipment integration
- Material tracking & genealogy
- Quality checks & analytics
Typical Timeline: 6-18 months Industries Served: Pharmaceutical, biologics, medical devices, specialty chemicals, food & beverage (regulated)
SAP Manufacturing & Integration
Deep expertise in SAP manufacturing modules tailored for pharmaceutical and regulated industries.
Core Capabilities:
- SAP PP & PP-PI implementation
- SAP QM for GxP compliance
- SAP MM for pharma supply chain
- MES-to-ERP integration
- Master data & traceability
Typical Timeline: Varies by scope
System-Agnostic Approach: While we're experts in SAP, we provide objective recommendations based on your specific manufacturing requirements—not vendor relationships.
Validation & Regulatory Compliance
GAMP 5 computer system validation and regulatory compliance services ensuring your manufacturing systems meet FDA, EMA, and global GxP requirements.
Services Include:
- Computer System Validation (CSV) - Validation documentation
- Risk assessments & traceability
- Data integrity (ALCOA+)
- 21 CFR Part 11 & EU Annex 11
- Regulatory audit support
Typical Timeline: 3-9 months
Our validation approach ensures compliance is built into your system architecture from day one—not retrofitted after implementation.
What Defines Us
Swift delivery accelerating time-to-market
Our productized SiMPL solution accelerates deployment by 40-60% compared to custom development. Get your manufacturing operations validated and production-ready faster without sacrificing quality or compliance.
Speed
Flexibility adapting to changing requirements
When requirements evolve mid-project, we pivot seamlessly to maintain compliance. Our pharmaceutical experience means we anticipate changes and adjust without extending timelines.
Agility
Unwavering commitment to client goals and measurable outcomes
We ensure systems address actual production needs and regulatory requirements— not technical capabilities. This eliminates scope creep and delivers validated, audit-ready solutions.
Focus
Streamlined processes with optimized resource allocation
We leverage proven frameworks from pharmaceutical implementations, avoiding reinvention of common solutions. Our accelerators reduce documentation time by 40-60% while maintaining compliance.
Efficiency
Well-architected, reliable, validated systems
Our GAMP 5 validated implementations withstand FDA/EMA scrutiny. We architect validation and audit readiness into foundations from day one—not afterward.
Precision and Excellence
Thriving independently or as part of larger teams
We work effectively with manufacturing, quality, IT, and validation teams. Whether independent or embedded, we create unified efforts that drive successful outcomes.
Collaboration
Our Story
Founded in 2021 in Vancouver, Canada, Lark & Stern Consulting Inc. specializes in manufacturing systems implementation for pharmaceutical and regulated industries. We deliver tailored solutions for the unique challenges of GxP manufacturing environments.
Our strategic partnership with Pangaea Solutions positions us as a premier implementer of SiMPL—their Electronic Batch Record accelerator built within SAP. This productized solution delivers faster implementations with lower risk compared to custom development approaches.
From our Canadian headquarters, we serve pharmaceutical leaders including AstraZeneca, Bristol Myers Squibb, ThermoFisher Scientific, and STEMCELL Technologies. Our South African delivery center provides world-class consulting at competitive rates with strategic timezone coverage for European and North American clients. We're committed to delivering validated, compliant systems that drive manufacturing excellence.
Trusted by Industry Leaders
We're proud to serve pharmaceutical and life sciences leaders who demand excellence in manufacturing systems implementation. Our clients range from innovative biotechnology companies to global pharmaceutical manufacturers— all united by their commitment to quality, compliance, and operational excellence.
Through our strategic partnership with Pangaea Solutions and deep expertise in SAP and MES platforms, we deliver validated solutions that drive manufacturing excellence across the pharmaceutical industry.
