Accuprec Research Labs

What Accuprec Research Labs does

Accuprec Research Labs Pvt. Ltd. is an India-headquartered Contract Research Organization (CRO) founded in 2012 by Dr. Rina Gokani in Ahmedabad, Gujarat. The company provides integrated testing and research services across five verticals: pharmaceuticals and APIs, medical devices, food, AYUSH/herbal products, and agrochemicals. Its service portfolio spans analytical testing (nitrosamines, NDSRIs, elemental impurities, extractables and leachables), ISO 10993 biocompatibility testing, preclinical toxicology, microbiological services, stability studies, packaging testing, formulation and R&D, clinical studies (Phase I-IV), regulatory dossier preparation (CTD/eCTD for US, Canada, EU, Brazil, Japan, China), and IPR management. Underlying capability rests on a 120,000+ sq.ft. facility on a 5-acre Ahmedabad campus equipped with LC-MS/MS, ICP-MS, HPTLC, ELISA, and walk-in stability chambers, with 250+ professionals including 150+ scientists.

Accuprec operates as a professional services, project-based CRO with quote-based pricing customized to client study protocols. Go-to-market is direct enterprise sales via business development executives, supported by regional offices in Delaware and Pittsburgh (USA) and Hamilton (Canada), trade show participation (WHX Osaka, WHX Miami, ICSCE), and digital channels (website, LinkedIn, YouTube). The company serves 1,000+ clients across 60+ countries, with primary customer segments being pharmaceutical companies and medical device manufacturers requiring ISO 10993, EU MDR, USFDA 510(k), and ICH-compliant testing data.

The business is differentiated by 20+ national and international accreditations including USFDA registration, OECD GLP, AAALAC, NABL ISO/IEC 17025:2017, ASCA (A2LA), EMA, Health Canada DEL, BIS, CDSCO MD-40, and AYUSH, with a clean April 2026 USFDA on-site audit (zero observations). Leadership combines founder Dr. Rina Gokani (Director & CSO), CEO Dr. Manish Rachchh (DABT, ERT-UKRT certified toxicologist), Managing Director Shri Mulubhai Kandoriya, and CMO Mayur Kandoriya. The company is privately held and founder-controlled, with no disclosed external funding.

Name

Accuprec Research Labs

Legal name

Accuprec Research Labs Pvt. Ltd.

Website

https://accuprec.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

101–250 employees

Short description

Accuprec Research Labs is an India-based Contract Research Organization providing accredited analytical, biocompatibility, preclinical, clinical, and regulatory dossier services to 1,000+ pharmaceutical and medical device clients across 60+ countries from a 120,000+ sq.ft. Ahmedabad facility with USFDA, OECD GLP, and ASCA certifications.

Ownership category

akta.pro rank

Product category

Contract Research and Testing Services (CRO)

NAICS

Testing Laboratories and Services (54138)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

Clinical CROs (Phase I–IV) (HLAGAAAA), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Central Laboratory & Clinical Trial Testing CROs (HLAGAAAE)

Keywords

• Contract research services
• Biocompatibility testing
• Pharmaceutical analytical testing
• Medical device testing
• Preclinical toxicology

Headquarters

HQ city

Ahmadabad

HQ country

India

HQ region

Asia

Offices5 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales, Supply Chain

Revenue model

1. Contract Research and Testing Services: Accuprec generates revenue through providing contract research and testing services across pharmaceuticals, medical devices, food, and regulated products. Services include analytical testing, preclinical toxicology, biocompatibility testing, stability studies, clinical services, and regulatory dossier preparation. Revenue is project-based with customized quotes for each client engagement.
2. Regulatory Dossier Preparation: Preparation of CTD and eCTD dossiers for global markets (USA, Canada, Europe, Brazil, Japan, China) as a fee-for-service professional service.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels6 records

Core offering

Accuprec Research Labs is a Contract Research Organization (CRO) providing integrated analytical testing, biocompatibility evaluation, preclinical toxicology, microbiological testing, stability studies, formulation development, clinical services, and regulatory dossier preparation for pharmaceutical, API, medical device, food, cosmetics, and AYUSH/herbal manufacturers. Services are delivered from an ISO/IEC 17025, OECD GLP, AAALAC, and USFDA-audited laboratory with global offices in India, USA, and Canada serving 1,000+ clients across 60+ countries.

Product overview

Accuprec Research Labs Pvt. Ltd. is a Contract Research Organization (CRO) offering a comprehensive, integrated portfolio of testing and research services for pharmaceuticals, medical devices, food, cosmetics, and herbal/AYUSH products. The company operates from a 120,000+ sq.ft. facility in Ahmedabad with global offices in Delaware, USA and Hamilton, Canada. The service portfolio includes core offerings such as Analytical Testing of Pharmaceuticals & Cosmetics, ISO 10993 Biocompatibility Testing, Preclinical & Toxicological Services, Microbiological Services, Stability Testing Services, Medical Device Testing, Clinical Services, Regulatory Dossier Preparation, Formulation & Development Services, and IPR Management Services. The company holds 20 national and international accreditations including NABL (ISO/IEC 17025:2017), GLP, OECD GLP, AAALAC, USFDA, EMA, and ASCA (A2LA), and serves more than 1,000 global clients across 60+ countries with 250+ scientific professionals.

Differentiator

Problem solved

Functional benefit

Products and services

• Analytical Testing of Pharmaceuticals & Cosmetics Comprehensive analytical testing services for pharmaceutical and cosmetic products including nitrosamine impurities testing, NDSRI testing, extractables and leachables studies, elemental impurity analysis, and comparative dissolution studies using LC-MS/MS, ICP-MS, and other validated techniques, for pharma and cosmetics manufacturers.
• Biotechnological Services Specialized testing for biologics, biosimilars, recombinant proteins, vaccines, and advanced therapeutic products including cell-line studies, ELISA testing, protein analysis, and immunogenicity assessment, for biopharmaceutical developers.
• Microbiological Services for Formulations Comprehensive microbiological testing for pharmaceutical and cosmetic formulations including microbial limit testing, sterility testing, bacterial endotoxin testing, and pathogen identification, for pharma and cosmetics manufacturers.
• Bio-Compatibility Studies of Medical Devices Biological safety evaluation services for medical devices including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, and hemocompatibility studies, for medical device manufacturers.
• ISO 10993 Biocompatibility Testing Comprehensive biocompatibility testing aligned with ISO 10993-1:2018 standards for medical devices including cytotoxicity, sensitization, irritation, genotoxicity, implantation, hemocompatibility, and chemical characterization testing, for medical device manufacturers.
• Preclinical & Toxicological Services Preclinical and toxicological testing including acute toxicity, repeated dose toxicity, DART studies, genotoxicity, carcinogenicity, and toxicological risk assessment aligned with OECD, ICH, and EMA standards, for pharmaceutical, nutraceutical, and agrochemical developers.
• Packaging Material & Plastic Testing Services Testing services for packaging and plastic materials including migration studies, extractables and leachables analysis, heavy metal testing, MVTR studies, RoHS testing, and USP Class VI testing, for packaging manufacturers and pharma/device companies.
• Stability Testing Services Accelerated and real-time stability testing for pharmaceuticals, chemicals, medical devices, and IVD products including all-zone stability testing, transport simulation studies, and walk-in stability chambers, for pharmaceutical and medical device manufacturers.
• Phytochemical & AYUSH Testing Services Comprehensive testing for herbal and AYUSH products including TLC, HPLC, HPTLC analysis, heavy metal testing, pesticide and aflatoxin analysis, and standardization of Ayurvedic medicines, for AYUSH and herbal product manufacturers.
• Food Testing Services Food and agricultural product testing aligned with FSSAI, BIS, EIC/EIA, APEDA, and EU standards including pesticide residue analysis, mycotoxin testing, nutritional labeling, and shelf-life estimation, for food processors and agricultural exporters.
• Formulation & Development Services End-to-end pharmaceutical formulation development including controlled release formulations, QbD approaches for NCE development, scale-up production, novel drug delivery systems, and technology transfer for commercial manufacturing, for pharmaceutical companies.
• Research & Development Services R&D services including reverse engineering of RLD formulations, innovative formulation development, synthesis and process development, and nanotechnology-based research for pharmaceutical and cosmetic products, for pharma and cosmetics manufacturers.
• Clinical Services Clinical research services including BA/BE studies, clinical trials (Phase I-IV) for synthetic and herbal drugs, clinical site management, and clinical trial protocol preparation aligned with ICMR and ICH-GCP guidelines, for pharmaceutical and AYUSH manufacturers.
• Regulatory Dossier Preparation Preparation of CTD and eCTD dossiers for global markets including USA, Canada, Europe, Brazil, Japan, and China for pharmaceutical, herbal, and medical device products, for manufacturers seeking multi-market regulatory submissions.
• IPR Management Services Intellectual property services including patent search, drafting, filing, trademark services, PCT application preparation, IP valuation, and technology transfer support, for pharmaceutical and medical device innovators.
• Physico-Chemical Testing of Raw Material & Finished Medical Devices Chemical characterization and testing for raw materials and medical devices including ISO 10993-18, breathing gas pathway testing (ISO 18562), residual EO/ECH testing, and TSE/BSE testing, for medical device manufacturers.
• Medical Device Packaging Testing Medical device packaging integrity testing and validation including ISO 11607-1/2, performance testing of medical-grade paper and Tyvek pouches, and sterilization validation, for medical device manufacturers.
• Stability Testing Services (Medical Devices & Packaging) Stability and transport testing for medical devices and packaging including accelerated stability studies (ASTM F1980), real-time stability studies, and transport simulation testing (ASTM D4169 and ISTA), for medical device manufacturers.
• Medical Device Microbiological Testing Services Medical device microbiological testing including bioburden testing, sterility testing, bacterial endotoxin testing, sterility assurance level testing, and environmental monitoring services, for medical device manufacturers.
• Biological Testing of Raw Materials Biological testing for plastics, rubber, silicone, and polymers as per IP, BP, EP, JP, and USP pharmacopeial standards including in-vitro and in-vivo cytotoxicity and toxicity testing, for medical device and pharmaceutical manufacturers.
• Performance Testing of Medical Devices Performance testing for medical devices including syringes, needles, IV sets, blood bags, catheters, sutures, intraocular lenses, orthopedic implants, and condoms as per ISO, ASTM, IS, and USP standards, for medical device manufacturers.
• Mask, PPE, Gloves & Textile Testing Testing services for PPE and medical textiles including surgical face masks (IS 16289, EN 14683), N95/FFP respirators, PPE kits, medical gloves, surgical gowns, and nonwoven fabrics, for PPE manufacturers and textile producers.
• Medical Device Research & Development Services Advanced R&D for medical devices including in-vitro and in-vivo model development, chemical and nano-bio sensor development, innovative device design, and coating technologies for drug-coated devices, for medical device innovators.
• Medical Device Clinical Study Clinical evaluation and trial services for medical devices including Clinical Evaluation Report (CER) preparation as per EU MDR 2017 and clinical trials per ICMR, CDSCO, and ICH-GCP guidelines, for medical device manufacturers.
• Performance Testing of Rapid In-Vitro Diagnostic Kits Performance testing for rapid diagnostic kits including HCG, malaria, HIV, dengue, blood glucose, and hemoglobin testing kits with accuracy and sensitivity evaluation, for IVD kit manufacturers.
• Medical Device Regulatory Dossier Preparation Services Medical device regulatory dossier preparation including EU MDR dossiers, ASEAN CSDT dossiers, and US FDA 510(k) submissions for market approvals, for medical device manufacturers.

Quantifiable outcome

• Zero observations in USFDA audit (April 2026)
• +2 more outcomes

Named customers2 records

Segments5 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Two partnerships are on record, tiered core.

• Yamuna Expressway Industrial Development Authority (YEIDA)coreStrategic or Co-development PartnerAccuprec is planning to establish ASCA-certified testing laboratories at the medical device park in Sector 28, Noida in collaboration with YEIDA. The project aims to create globally accepted testing infrastructure aligned with USFDA standards, involving infrastructure upgrades and new testing modules.
• Strategic Alliance - USAcoreStrategic or Co-development PartnerStrategic alliance in the USA to support global testing excellence and expand North American market presence. Global branch offices established in Delaware, USA and Hamilton, Canada.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Broad incumbents

• Intertek: Global TIC provider with significant pharmaceutical, medical-device, and agri-food testing exposure. Competes for the same multinational testing RFPs Accuprec targets.
• IQVIA: Largest global CRO with full clinical, real-world, and laboratory services. Sets the preferred-provider standard Accuprec must outperform on cost or specialization to win large pharma accounts.
• SGS: World's largest testing, inspection, and certification company. Competes across Accuprec's food, pharmaceutical, and medical-device testing lines, particularly for multinational clients seeking single-vendor global coverage.
• Charles River Laboratories: Global CRO with industry-leading preclinical and safety assessment (GLP/AAALAC) capabilities. Direct incumbent competing for Accuprec's core toxicology, biocompatibility, and medical-device testing work.
• Eurofins Scientific: Global leader in testing services with deep pharmaceutical, medical-device, food, and agrochemical testing portfolios. Sets pricing benchmarks Accuprec competes against across its entire service menu.

Direct peers

• Vimta Labs: Indian CRO and testing services provider offering analytical, preclinical, clinical, and food testing. Closest publicly listed Indian comparable in scale and service breadth, headquartered in Hyderabad with international accreditations.
• Veeda Clinical Research: India-based CRO providing preclinical toxicology, clinical research (BA/BE), and bioanalytical services. Direct competitor for pharmaceutical testing contracts from global sponsors seeking India-based execution.
• Syngene International: Indian integrated CRO/CDMO offering discovery, development, and manufacturing services. Larger but closest large-cap domestic peer; competes for similar pharma and medical-device testing mandates.

Emerging players

• WuXi AppTec: Asia-based (China) integrated CRO/CDMO with broad pharma testing capabilities. Geographically distinct but competes for global sponsors' outsourced testing budgets, particularly for cost-sensitive analytical and preclinical work.
• TUV SUD (Medical Health Services): Global TIC player with active medical-device testing and biocompatibility services. Overlaps with Accuprec's medical-device biocompatibility and ISO 10993 work for EU and Asian medtech clients.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights6 records

Customer concentration

• Xx.com/accupreclab
• YouTubeyoutube.com/channel/UC7m2mT-I2aoLTTgX-ZCAWdA
• Facebookfacebook.com/accuprec
• LinkedInlinkedin.com/in/accuprec
• Instagraminstagram.com/accuprec

Compliance18 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Accuprec Research Labs