Our Services

Comprehensive consulting across Quality Management, Regulatory Affairs, Lean & Process Excellence, Digitalization, and Training — tailored to your organization.

Quality Management Services

A well-structured Quality Management System is the backbone of any organization's quality improvement efforts. At Emerging Sigma, we design QMS solutions that are integrated, lean, digitization-friendly, and self-sustaining — covering the full spectrum from system development to product, supplier, and warehouse quality.

ISO 13485ISO 9001IATF 16949AS9100MDSAPGxP
01

QMS Development & Certification

  • Gap analysis & QMS roadmap development
  • Integrated multi-standard QMS frameworks
  • Lean, digitization-friendly documentation
  • Certification audit preparation & support
  • Post-audit CAPA and continuous improvement
02

Product Quality Management

  • New product development quality & safe launch
  • In-process & finished goods quality control
  • Packaging & logistics quality validation
  • Cold chain validation & transportation studies
  • Process capability & data-driven improvement
03

Supplier Quality Management

  • Supplier selection, audit & qualification
  • Performance monitoring & scorecard systems
  • Six Sigma-based supplier improvement programs
  • Defect reduction & CAPA management
  • End-to-end modular SQM services
04

Warehouse Quality Management

  • Warehouse QMS development (ISO 13485, GMP)
  • Inward inspection & storage control processes
  • Regulatory compliance review (FDA, CDSCO, GDP)
  • Cold chain & product preservation compliance
  • Annual compliance monitoring (AMC) services
05

Equipment Qualification

  • URS, DQ, IQ, OQ, PQ — full qualification lifecycle
  • Risk-based validation strategy
  • Process capability & MTTR/MTBF studies
  • Qualification dossier assembly
  • GAMP 5, FDA 21 CFR 11, EU GMP Annex 1
06

Data-Driven Quality Improvement

  • Statistical Process Control (SPC)
  • Measurement System Analysis (MSA)
  • Design of Experiments (DOE)
  • FMEA & risk management (ISO 14971)
  • KPI framework development & monitoring

Regulatory Affairs Services

Comprehensive regulatory services for medical device and healthcare organizations — from strategic market entry planning through to post-market compliance. We cover manufacturing, imports, exports, and the full approval lifecycle across global markets.

EU MDR 745IVDR 746US FDA 510(k)CDSCO MDR 2017WHO PQPMDAANVISA
01

Regulatory Strategy & Approval Pathways

  • Product classification & risk assessment
  • Market entry strategy: Import, Manufacturing, Private Labelling
  • Regulatory approvals: EU MDR, US FDA 510(k)/PMA, WHO PQ, PMDA, ANVISA, Health Canada
  • Regulatory roadmap & timeline planning
02

Technical Documentation & Compliance

  • Technical file & design dossier preparation
  • Site master file & dossier development
  • Performance Evaluation Report (PER) support
  • Risk assessment documentation (ISO 14971)
  • Regulatory labelling compliance
03

License Applications & Approvals

  • Manufacturing, import & test licenses
  • Wholesale & loan license applications
  • CDSCO MD-14, MD-26, MD-42 applications
  • ICMR product approvals & BIS certifications
  • Regulatory certificates (NCC, MSC, FSC)
04

Clinical Investigation & Performance Evaluation

  • Clinical investigation & performance evaluation plans
  • Ethics committee coordination & submissions
  • Clinical data analysis & report compilation
  • Regulatory approvals for clinical studies
05

QMS Compliance & Audit Support

  • QMS development & gap analysis
  • GxP compliance: GMP, GLP, GDP
  • Risk management as per ISO 14971
  • Notified body audit preparation & support
  • Post-audit CAPA management
06

Post-Market Compliance

  • Post-market surveillance (PMS) system implementation
  • Adverse event reporting & PSUR preparation
  • Post-market clinical follow-ups (PMCF)
  • Change management & license renewals
  • Ongoing regulatory compliance monitoring

Lean & Process Excellence

Six Sigma Black Belt-led process improvement programs that deliver measurable, time-bound results. We eliminate waste, streamline operations, and build data-driven improvement capability within your organization.

Six Sigma DMAICSPCDOEMSAVSMKaizen
01

Six Sigma Improvement Programs

  • DMAIC project scoping & execution
  • Root cause analysis & statistical problem solving
  • Process capability studies (Cp, Cpk)
  • Control plan development & sustaining phase
02

Process Mapping & Optimization

  • Value stream mapping (VSM)
  • Process documentation & SOP development
  • Waste identification & elimination
  • Setup time, cycle time & throughput studies
03

Operational Excellence

  • KPI framework development & deployment
  • Performance monitoring & dashboard design
  • Cross-functional improvement workshops
  • Continuous improvement culture building

Digitalization

We design quality and compliance systems that are digitization-ready from day one — enabling seamless transition from paper-based operations to scalable digital infrastructure without disrupting regulatory compliance.

01

Digital QMS Transformation

  • Paper-to-digital process migration strategy
  • eQMS system selection & implementation support
  • 21 CFR Part 11 compliance for electronic records
  • Electronic document & record control systems
02

Process Digitalization

  • Digital SOPs, forms & workflow automation
  • Digital audit trail & traceability systems
  • KPI dashboards & real-time monitoring tools
  • Training management system (TMS) design
03

Compliance Data Management

  • Regulatory submission tracking systems
  • License & approval management tools
  • Complaint handling & CAPA digital workflows
  • Supplier quality data management

Training Programs

Structured training programs covering quality fundamentals to advanced Six Sigma tools — delivered online or onsite, customized to your organization's level and industry context, with effectiveness monitoring built in.

01
Level One
QMS Fundamentals
Introduction to Quality Management Systems, regulatory and customer requirements, document & record control, internal audit basics.
02
Level Two
Basic Quality Tools
7 QC tools, root cause analysis, FMEA, risk assessment techniques, control plans, and basic statistical concepts.
03
Level Three
Advanced Data Analysis
Statistical Process Control (SPC), Measurement System Analysis (MSA), process capability studies, and data interpretation.
04
Level Four
Advanced Problem Solving
Design of Experiments (DOE), Six Sigma DMAIC methodology, Lean process improvement, and advanced CAPA techniques.
Delivery
Training Delivery Model
Online & onsite formats, suitable for all organizational levels, workshop-style practical sessions, relevant case studies, effectiveness monitoring.
Specialized
Auditor Development
Internal auditor training for ISO 13485 and ISO 9001, regulatory audit preparation programs, CAPA team training.