We provide expert validation and project support, so you can move forward with confidence in the speed and efficiency of your product’s journey, because we know how crucial cost and time to market are.

ekte ogranic chemistry

Strategic Project Planning

Plan to succeed! Involving the right experts early can result in massive time and cost savings in any complex project and may mean the difference between success and failure. Get a complimentary advisory call with our experts today and proceed with confidence.

Product Development and Design Control

What if you could halve your time to market at comparable cost? Our team specializes in finding efficient paths to product approval and commercial release, then getting the right people on the team to make sure it gets done correctly and efficiently.

cGMP Manufacturing Establishment

Establishing new manufacturing capabilities and facilities doesn’t have to be a multi-year project. We can help your organization achieve velocity, lay the foundations for decades of success, and realize your ambitions.

Operations and Sustaining Engineering

Every organization faces quality, regulatory, and engineering challenges during routine operations. Ekte is your complete life-cycle partner. We offer on-demand subject matter expertise, advice, and nimble project teams to keep your operation running smoothly

No matter what you need – we’re with you every step of the way.

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Pharma

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Medical Device

Human Cell & Tissue

Biological Drug

Supplement

Decades of Expertise

Operations

Validations
Engineering

  • Equipment Qualification (IQ, OQ, PQ)
  • Facility Qualification

  • Process Validation (PV, PPQ)

  • Cleaning Validation
  • Sterilization Validation
  • Test Method Validation (Gage R&R)
  • Analytical Method Validation
  • Validation Risk Management
  • Validation Life-Cycle Approach Establishment
New Product New Market

New Product / New
Process Development

  • Product Development Strategy
  • Design Control Implementation
  • DHF Development
  • Product Risk Management

  • Material Quality Management

  • Product Verification and Validation
  • Quality by Design (QbD)
  • SOP / Work Instruction Development
  • Tech Transfer / Process Design
Improvement

Quality
Engineering

  • Quality Risk Management
  • Quality System Development
  • Lean Waste Reduction and Operational Excellence
  • Internal Auditing
  • Defect / Non-Conformity / Error Reduction
  • Corrective and Preventative Action
  • Manufacturing Process Risk Management
  • Post-Market Surveillance
  • Change Control/Change Management
  • Lean Six-Sigma
Validations

Sterility Assurance

  • Cleanroom Qualification
  • Cleanroom Environmental Monitoring
  • Cleanroom Environmental Control
  • Sterilization Process Development
  • Sterilization Validation
  • Cleaning Process Development
  • Cleaning Validation
  • Aseptic Manufacturing Validation
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Supplier Quality Assurance

  • Supplier Identification
  • Supplier Risk Management
  • Vendor/Supplier Qualification
  • Supply Chain Resiliency
  • Inspection Plan Development
  • Supply NC Evaluation and Disposition

Put Our Expertise to Work for You