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Official Qualifications & Licences

Accreditations & Regulatory Recognition

Doctors’ Analytical Laboratories Pvt. Ltd. maintains documented accreditation, regulatory inspection records and product-specific registrations relevant to its laboratory operations and testing activities.

Explore the certificates and supporting documents below. Each record should be interpreted within its stated scope, conditions and validity period.

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ISO/IEC 17025:2017

NABL accredited testing laboratory (TC-13569) with integrated IOPEPC and APEDA scope annexures.

Regulatory Inspections

Documented inspection records from Health Canada (Compliant GMP) and US FDA (Classified NAI).

Licence & Export Schemes

Maharashtra FDA licence retention and Sri Lanka Standards Institution (SLSI) pre-export registration.

Accreditation

Laboratory Accreditation

Doctors’ Analytical Laboratories Pvt. Ltd. holds NABL accreditation to ISO/IEC 17025:2017 for its testing facility in Rabale, Navi Mumbai, alongside integrated export development council scope annexures.

ISO/IEC 17025:2017 NABL Certificate of Accreditation — ISO/IEC 17025:2017
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NABL TC-13569

NABL Certificate of Accreditation — ISO/IEC 17025:2017

Doctors’ Analytical Laboratories Pvt. Ltd. holds NABL accreditation to ISO/IEC 17025:2017 for testing at its facility in Rabale, Navi Mumbai. The accreditation applies to the scope specified in the relevant annexure. Please consult the scope documents for the listed products, parameters, methods and applicable testing ranges.

Certificate No.: TC-13569
Issue Date: 13 January 2026
Valid Until: 12 January 2028
Accreditation Field: Testing
Facility: Plot No. R-809, TTC, MIDC Rabale, Navi Mumbai
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Integrated Scope 79 Scope Pages Integrated NABL Scope — IOPEPC Certificate and Annexure
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NABL & IOPEPC TC-13569

Integrated NABL Scope — IOPEPC

The integrated NABL scope document identifies the Indian Oilseeds & Produce Export Promotion Council (IOPEPC) alongside NABL and contains the listed scope of testing under ISO/IEC 17025:2017.

Certificate No.: TC-13569 (Integrated)
Council: IOPEPC
Scope Validity: 9 April 2026 to 12 Jan 2028
Document Content: Certificate & 79 Scope Pages
Scope Notice: Includes 79 scope pages. Refer to the annexure for exact products and parameters. The entire laboratory portfolio is not covered by this integrated scope.
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Integrated Scope 72 Scope Pages Integrated NABL Scope — APEDA Certificate and Annexure
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NABL & APEDA TC-13569

Integrated NABL Scope — APEDA

The integrated NABL scope document identifies the Agricultural & Processed Food Products Export Development Authority (APEDA) alongside NABL and contains the listed food and agricultural testing scope under ISO/IEC 17025:2017.

Certificate No.: TC-13569 (Integrated)
Authority: APEDA
Scope Validity: 13 Jan 2026 to 12 Jan 2028
Last Amended: 9 April 2026
Document Content: Certificate & 72 Scope Pages
Scope Notice: Includes 72 scope pages. Refer to the annexure for exact products, parameters, methods and testing ranges.
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Foreign Health Authorities

Regulatory Inspection Records

The records below document formal regulatory inspections conducted by foreign health authorities. These represent specific inspection histories and outcomes for pharmaceutical testing activities, rather than blanket facility accreditations.

Regulatory Inspection Health Canada — Drug & Health Product Inspection Record
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Health Canada Ref: 511359

Health Canada — Drug & Health Product Inspection Record

The supplied Health Canada record lists Doctors’ Analytical Laboratories Pvt. Ltd. under pharmaceutical testing activities. It records compliant GMP foreign evidence assessments dated 27 June 2022 and 30 October 2017.

Reference Number: 511359
Activity Category: Test (Pharmaceutical)
Record Type: Drug & health product inspections
Assessment Dates: 27 June 2022 & 30 Oct 2017
Assessment Result: Compliant GMP Foreign Evidence
Inspection Notice: This is an inspection record, not a general accreditation certificate. It describes Health Canada inspection records and does not imply that Health Canada accredits all DALPL services.
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US FDA EIR (NAI) US FDA — Establishment Inspection Report (2022)
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US FDA FEI: 3009890383

US FDA — Establishment Inspection Report (2022)

The supplied US FDA correspondence and report relate to a pre-approval inspection conducted at the laboratory from 27 June 2022 to 29 June 2022. The report summary states that the inspection was classified as NAI (No Action Indicated) and that no Form FDA 483 was issued. The inspection concerned the laboratory’s contract-testing work related to platinum content in Sapropterin Dihydrochloride API for a specified product.

FEI: 3009890383
Inspection Dates: 27–29 June 2022
Classification: NAI (No Action Indicated)
Form FDA 483: None Issued
Inspection Type: Pre-Approval Contract Testing
Inspection Notice: This is a historical US FDA inspection report. It does not constitute FDA accreditation, FDA certification, or a blanket approval of every DALPL test or service.
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Statutory & Trade Registrations

Licence & Export-Related Registration

State manufacturing and testing licence retention documents along with international pre-export inspection scheme approvals for designated commodities.

State Licence Retention Maharashtra FDA — Licence Retention
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Maharashtra FDA Licence: 37-MH/102511

Maharashtra FDA — Licence Retention

The supplied Maharashtra Food & Drugs Administration (Konkan Division) document records retention of a licence with products for Doctors’ Analytical Laboratories Pvt. Ltd.

Licence Number: 37-MH/102511
Validity Period: 29 Jan 2023 to 28 Jan 2028
Document Date: 5 February 2023
Issuing Division: Konkan Division, Maharashtra
Licence Notice: Designated as Maharashtra FDA Licence Retention rather than "FDA accreditation". Displayed licence details should be verified against current official records before publication.
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Import Inspection Scheme Sri Lanka Standards Institution — Import Inspection Scheme Registration
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Sri Lanka Standards Institution SLS 1563:2017

Sri Lanka Standards Institution — Import Inspection Scheme Registration

The supplied letter from the Sri Lanka Standards Institution (SLSI), dated 28 July 2025, confirms registration of Doctors’ Analytical Laboratories Pvt. Ltd. under SLSI’s Import Inspection Scheme for issuing pre-export quality certificates for consignments of chilli (whole and ground).

Issuing Body: Sri Lanka Standards Institution
Letter Date: 28 July 2025
Registration Scope: Chilli (whole and ground)
Standard Reference: SLS 1563:2017
Stated Test Scope: Moisture, ash, aflatoxin, E. coli, etc.
Product-Specific Notice: Product-specific registration under an import inspection scheme, not a general international accreditation. Registration validity is subject to laboratory agreement to registration conditions.
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How to Interpret DALPL Accreditation & Regulatory Documents

Scope-Specific Parameters: Laboratory accreditation applies strictly to the listed products, test parameters, standard test methods, and measurement ranges documented in official annexures.
Multi-Page Scope Annexures: Integrated NABL scope documents include comprehensive multi-page annexures (79 pages for IOPEPC and 72 pages for APEDA). The thumbnail preview reflects the certificate cover.
Regulatory Inspection Distinctions: Records from Health Canada and the US FDA represent specific inspection findings (including US FDA NAI classification with no Form FDA 483 issued), not general facility certifications.
Product-Specific Registrations: The SLSI approval applies specifically to pre-export quality certification for consignments of chilli (whole and ground) under SLS 1563:2017 conditions.

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