Biocompatibility Testing
“Accuprec performs comprehensive biocompatibility evaluations of medical devices in line with ISO 10993‑1:2018 standards, including in vitro cytotoxicity (ISO 10993‑5) and skin sensitization testing (ISO 10993‑10). This ensures materials and devices are safe for human use before regulatory submission.”
Biological Testing of Raw Material
“We provide testing services for materials like plastic, rubber, silicone, and polymers to make sure they are safe and suitable for use in medical and pharmaceutical products. These tests help check for harmful effects on the body, such as irritation or allergic reactions, and follow international standards like IP, BP, EP, JP, and USP.”
Packaging Testing
“We offer packaging testing services to evaluate the strength, integrity, and safety of medical and pharmaceutical packaging. Our tests follow global standards like ISO 11607, ISO 11135, ISO 11140, and others to ensure packaging meets regulatory requirements for sterilization, shelf life, and product protection.”
Stability Testing
“We provide stability testing for pharmaceuticals, chemicals, and medical devices, including real-time and accelerated studies as per ICH, ASTM, and WHO guidelines to ensure product shelf life and reliability.”
Mask, PPE, Gloves & Textile Testing
“We offer testing for masks, PPE kits, gloves, gowns, and medical textiles to ensure safety, protection, and compliance with ISO, ASTM, EN, and NIOSH standards.”
Research & Development Services
“Accuprec’s R&D division designs and develops innovative medical solutions, including in vitro and in vivo models, advanced chemical and nano-biosensors for rapid diagnostics, custom medical devices, and specialized coating technologies—all tailored to meet client needs and support breakthrough research.”
Performance Testing of Rapid In-Vitro Diagnostic Kits
“We perform comprehensive performance testing for rapid in‑vitro diagnostic kits, including HCG, malaria, and blood glucose assays, to ensure accuracy, sensitivity, specificity, and compliance with global diagnostic standards.”
Clinical Study
“Accuprec conducts Clinical Evaluation Reports (CERs) in compliance with EU MDR 2017 and manages clinical trials for medical devices under ICMR, CDSCO, EU MDR, and ICH-GCP guidelines”
Dyes, Pigment & Plastic Testing
“Accuprec provides testing for dyes, pigments, and plastics, including heavy metals, particle size, migration, biodegradability, extractables/leachables, moisture transmission, RoHS, and USP Class VI compliance.”
Regulatory Dossier Preparation Services
“We prepare comprehensive regulatory dossiers—including CTD/eCTD submissions for the USA, Canada, Europe, Brazil, and ASEAN regions, as well as 510(k) medical device dossiers for the U.S. and CSDT for ASEAN—covering both pharmaceutical (allopathic and herbal) and medical device products”
Physico-Chemical Testing
“We offer physico-chemical testing of raw materials and finished medical devices as per ISO, USP, CFR, and WHO standards to ensure safety, compliance, and material quality.”
IPR Management Services
“We offer testing for masks, PPE kits, gloves, gowns, and medical textiles to ensure safety, protection, and compliance with ISO, ASTM, EN, and NIOSH standards.”
Analytical Testing
“We prepare comprehensive regulatory dossiers—including CTD/eCTD submissions for the USA, Canada, Europe, Brazil, and ASEAN regions, as well as 510(k) medical device dossiers for the U.S. and CSDT for ASEAN—covering both pharmaceutical (allopathic and herbal) and medical device products”
Compatibility Studies of Medical Devices
“We provide comprehensive preclinical and toxicology testing—covering acute, sub‑acute, chronic, sensitization, irritation, genotoxicity, hemocompatibility, implantation, pyrogenicity, carcinogenicity, reproductive/developmental toxicity, pharmacokinetics, and efficacy models—following OECD, ICH, US FDA/EPA, and EU guidelines. “
Preclinical & Toxicological Services
“We provide biocompatibility testing of medical devices as per ISO 10993 standards, including cytotoxicity, skin sensitization, irritation, systemic toxicity, hemocompatibility, implantation, genotoxicity, and degradation studies to ensure safety and suitability for human use.”
Phytochemical Testing Services
“We provide phytochemical and AYUSH testing services including herbal identification, formulation analysis, contaminant screening, and standardization as per AYUSH and pharmacopeial guidelines.”
Food Testing
“Accuprec delivers comprehensive food and agrochemical testing—including pesticide residue analysis, banned dye detection, mycotoxin screening, nutritional profiling, microbiological safety checks, and packaging compliance—aligned with FSSAI, BIS, EU, and APEDA standards to ensure consumer safety and regulatory adherence. “
Formulation & Development Services
“Accuprec specializes in developing and optimizing pharmaceutical formulations, including sustained- and controlled-release systems, excipient screening, stability studies, pilot-scale productions, and custom dosage forms. Our expert team supports formulation design through to regulatory-ready batches, ensuring efficacy, safety, and scalability.”
