Who We Are

SMZY Consulting is a specialized partner supporting pharmaceutical, biopharmaceutical, and medical device industries in establishing world-class Extractables & Leachables programs.

⚙️ Our Core Services

🧩 E&L Consulting

Study design & strategy
Material selection & compatibility
Regulatory gap analysis (USP, ICH, FDA)

🏗️ Laboratory Setup

Full E&L lab design (GMP / GLP compliant)
Instrument selection & installation:
- GC-MS
- LC-MS/MS
Workflow & method development

🧪 E&L Studies

Extractables (worst-case profiling)
Leachables (real-time & stability studies)
Advanced chemical identification

⚠️ Risk Assessment

Compound identification
Exposure calculation
Toxicological evaluation (TTC-based)
Safety & compliance decisions

SMZY Consulting – Extractables & Leachables (E&L) Services

SMZY Consulting is a specialized scientific and regulatory consulting company that supports pharmaceutical, biopharmaceutical, and medical device industries in establishing and managing extractables and leachables (E&L) programs. The company provides end-to-end solutions—from laboratory setup to risk assessment studies and regulatory compliance.

Laboratory Setup (Building Your E&L Lab)

One of SMZY’s core services is designing and building a fully functional E&L laboratory.

A. Laboratory Design

Layout for sample preparation, extraction, and analysis
Separation of volatile and non-volatile testing areas
Compliance with GMP / GLP requirements

B. Required Equipment

SMZY helps select and install critical analytical instruments:

GC-MS → volatile & semi-volatile compounds
LC-MS / LC-MS/MS → non-volatile & polar compounds

These techniques are standard for identifying chemical migrants in E&L studies .

C. Supporting Infrastructure

Controlled extraction systems (temperature, solvents)
Stability chambers (real-time & accelerated studies)
Clean utilities (high-purity solvents, gases)
Data systems (LIMS, CDS)

D. Method Development & Validation

Develop screening methods (GC-MS, LC-MS)
Validate according to ICH guidelines
Transfer methods to QC labs if required

📊 Industries We Serve

Pharmaceuticals
Biologics
Medical Devices
Single-Use Systems

✅ Why SMZY?

✔ End-to-end solutions (Consult → Build → Test → Approve)
✔ Regulatory-focused approach
✔ Advanced analytical expertise
✔ Customized solutions for every client