Our Services

Technical Services

We have technical expertise to assist you in Panel Design, Instrument Selection, Method Optimization, Validation, SOP writing, Bioanalytical Method Development and Validations for the wide variety of tests including:

Molecular Microbiology (Infectious disease Panel)

1. Gastrointestinal Panel

2. Nail Fungal Panel

3. Wound Microbiota Panel

4. Respiratory Microbiota Panel (COVID panel)

5. Urinary Microbiota Panel

6. Sexually Transmitted Disease Panel (Male and Female)

7. Vaginitis Panel

Other complex Molecular Diagnostic panels

1. Pharmacogenomics Panel (qPCR)

2. Hereditary disorder panel (NGS)

3. Somatic cancer panel (NGS)

Toxicology

1. Urine Drug screening

2. Urine drug confirmation on LC-MS/MS

3. Pain management

4. Drug of abuse

5. Cannabis testing

Allergy testing

1. Food and Environmental allergy testing panel

2. Allergen component testing

3. IgE and IgG antibody detection

General Chemistry, Hematology

Direct to Consumer test and Lab Developed Tests (LDTs)

Data processing lab built (Dry lab)

Regulatory and Quality Compliance

Accreditation, Applications, Policies and Procedures

CLIA, COLA and CAP

Initial CLIA application (CMS 116)

COLA, CAP accreditation application

In-state and Out of state licensure application

NY CLEP permit application

NY LDT application

Establish and Maintain required Quality standards

FDA

Consulting on FDA LDT final rule

Consulting on 510K, PMA application

Consulting on Class !, 2, 3 medical devices

GLP, GCLP, ICH E6 R2/R3 (GCP)

Establish and Maintain required Quality standards

Laboratory Management

Manage High complex, moderate complex, CLIA waived, POL labs. Day to Day quality management, Risk management, CAPA

Staffing and Recruiting

1. Hire qualified and trained laboratory staff as per Federal and state standards.

2. Hire Part-time/Full-time qualified Lab Director as per state and federal regulatory requirements

3. Staff Training and Competencies

Quality Management

Daily Quality control monitoring

Periodic monitor of Quality indicators as per Quality Management plan

Quality assurance for pre analytic, Analytic and post analytic workflow of the test

Inspection Readiness and Mock Audits

Periodic MOCK inspection

Root cause analysis

Corrective and Preventative actions

Lab design and upfit

Design lab layout for efficient test workflow.

Proper placement of lab instruments and equipment.

Consulting on proper electrical, plumbing, interface, HVAC, and ventilation hood as per the manufacturer guidelines and all local, State, and Federal guidelines.

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