Accreditations, Licenses & Regulatory Approvals

Built on Compliance.
Driven by Quality.

VAPL operates within structured quality and regulatory frameworks supporting contract gamma irradiation services across medical device, food and pharmaceutical applications.

Explore Our Credentials ↓
VAPL ASSURANCE FRAMEWORK
QUALITY SYSTEM
01
Regulatory Framework Applicable operational requirements
02
Quality Management Defined systems and procedures
03
Industry Applications Medical device, food and pharma
04
Documented Processes Structured service delivery
Our Compliance Framework

The Framework Behind Every Process

Our certifications, regulatory licences and technical systems support structured irradiation service delivery across regulated industry applications.

01

Regulatory Oversight

Operations supported by applicable licences, regulatory requirements and oversight frameworks.

02

Quality Management Systems

Certified quality systems supporting documented procedures, process controls and consistent service delivery.

03

Industry-Specific Requirements

Regulatory frameworks supporting irradiation applications across medical devices, food and pharmaceuticals.

VAPL Regulatory Credentials

Quality Systems. Regulatory Licences.
Documented Confidence.

Explore the quality certifications and regulatory licences supporting VAPL's contract gamma irradiation operations.

01 / QUALITY MANAGEMENT

Certified Quality Management Systems

VAPL ISO 9001:2015 Certificate
BSI CERTIFICATION

ISO 9001:2015

Quality Management System certification for the provision of contract gamma irradiation sterilization services.

QUALITY MANAGEMENT CONTRACT IRRADIATION
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VAPL ISO 13485:2016 Certificate
BSI CERTIFICATION

ISO 13485:2016

Medical device Quality Management System certification for contract gamma irradiation sterilization services in accordance with ISO 11137-1:2025.

MEDICAL DEVICES ISO 11137-1
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02 / MEDICAL DEVICE REGULATORY

Medical Device Regulatory Framework

VAPL CDSCO Class A and B Licence
MEDICAL DEVICES RULES, 2017

CDSCO Class A & B

Regulatory licence supporting gamma irradiation services for Class A and Class B medical devices.

CLASS A CLASS B
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VAPL CDSCO Class C and D Regulatory Process
REGULATORY PROCESS

CDSCO Class C & D

Regulatory inspection process relating to VAPL's application to provide gamma irradiation services for Class C and Class D medical devices.

CLASS C CLASS D
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VAPL FSSAI Central Licence
FSSAI CENTRAL LICENCE

Radiation Processing of Food

Central licence authorising radiation processing of food at VAPL's irradiation facility.

FSSAI FOOD IRRADIATION
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04 / PHARMACEUTICAL REGULATORY

State Drug Regulatory Licences

VAPL Form 25 Licence
FDA MAHARASHTRA

Form 25 Licence

State regulatory licence supporting applicable gamma radiation processing activities under the Drugs and Cosmetics framework.

FORM 25 DRUG REGULATORY
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VAPL Form 28 Licence
FDA MAHARASHTRA

Form 28 Licence

State regulatory licence covering applicable products under Schedule C and C(1) of the Drugs and Cosmetics Rules.

FORM 28 SCHEDULE C & C(1)
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What It Means for Our Customers

Compliance That Supports Customer Confidence

Our regulatory and quality frameworks support structured processes, documentation and dependable irradiation service delivery.

Defined Processes

Operations supported by established procedures and process controls.

Documented Traceability

Processing and quality records supporting applicable customer requirements.

Technical Confidence

Structured technical practices supporting irradiation and validation activities.

Multi-Sector Capability

Regulatory frameworks supporting medical device, food and pharmaceutical applications.

Have a Regulatory or Quality Requirement?

Discuss your product, validation, documentation or irradiation processing requirements with the VAPL team.

Discuss Your Requirement →

Vishvesh Agromed Private Limited (VAPL) is a strategic sterilisation partner providing Contract Sterilisation Services, Dose Mapping & Validation, Dose Establishment Studies, and Radiation Dosimetry Services for medical devices, pharmaceuticals, packaging materials, food products and industrial applications.

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© 2023 Vishvesh Agromed Pvt. Ltd. All Rights Reserved. 
Designed By
Anubandhaka

© 2023 Vishvesh. All Rights Reserved. 
Designed By
Anubandhaka