Accuprec Research Labs Pvt. Ltd.

Services offered

Accuprec Research Labs Pvt. Ltd. ® is a service provider for various testing services required for pharmaceuticals, chemicals and phytochemicals as well as herbal formulations.

Biocompatibility Testing of Medical Devices (As per ISO 10993-1:2018)

In-vitro Cytotoxicity Testing (ISO 10993-5)
Skin Sensitization Testing (ISO 10993-10)
Irritation or Intracutaneous Reactivity Test (ISO 10993-23)

Biological Testing of Raw Material of Plastic, Rubber, Silicone, Polymers, etc.
(As per IP / BP / EP / JP / USP)

In-vitro Cytotoxicity Testing
In-vivo Intracutaneous Testing
In-vivo Acute Systemic Toxicity Testing

Microbiological Testing Services

Bioburden Testing & Its Validation (ISO 11737-1)
Sterility Testing & its Validation (ISO 11737-2)
Bacterial Endotoxin Testing & its Validation (USP <85> & USP <161>)

Packaging Testing

Packaging Integrity Testing & Validation Testing (ISO 11607-1 & ISO 11607-2)
Performance Testing of Medical Grade Paper & Tyvek Pouch
Sterilant Penetration Test (ISO 17665-1 & ISO 17665- 2, AAMI/ANSI/ISO 11135-1)

Stability Testing Services

All zones Stability Testing available
Accelerated Stability Study (ASTM F1980, ASTM D7160)
Real Time Stability Study (ASTM F1980, ASTM D7160)

Mask, PPE, Gloves & Textile Testing

Surgical Face Mask (IS 16289, EN 14683 & ASTM F2100)
N95/FFP Face Mask (ASTM F2100, EN 149 & NIOSH)
PPE kit (IS 16546 / ISO 16603)

Performance Testing of Medical Devices

Hypodermic Syringe (ISO 7886-1, ISO 7886-3, ISO 7864, ASTM F3212)
Sterile single use syringe for Insulin (ISO 8537)
Stainless Steel needle tubing (ISO 9626, IS 10654)

Performance Testing of Rapid In-Vitro Diagnostic Kits

HCG diagnostic kit
Malarial diagnostic kit
Blood Glucose monitoring kit

Research & Development Services

Development of In-vitro model to prove efficiency of Medical Devices.
Development of In-vivo model to prove efficiency of Medical Devices
Development of Chemical sensors for Rapid diagnosis purpose

Clinical Study

Clinical Evaluation Report (CER) as per the requirement of EU MDR 2017
Clinical trial of Medical Device as per ICMR, CDSCO, EU MDR and ICH-GCP guidelines

Regulatory Dossier Preparation Services

Preparation of Medical Device Dossier for EU(Europe) market

Physico-Chemical Testing of Raw Material & Finished Medical Devices

Chemical testing of Nylon Resin used in Packaging of Food material and in Medical Devices (21 CFR 177.1500)

IPR Management Services

Patent Search, Drafting & Filing
Trademark Search & Filing Services
Industrial Design Search & Filing Services

Analytical Testing of Pharmaceuticals, Cosmetics, Medical Devices & Agrochemicals

Analytical Testing of Pharmaceuticals & Cosmetics
API characterization and analysis Analytical method development
Bio-Analytical Method Development and Validation

Biotechnological Services

Cell-Line Study for New Molecules
Determination of Immunoglobulin using HPLC
ELISA Testing

Microbiological Services

Antibiotic Assays
Assay of Vitamins
Bio- Burden Testing

Bio – Compatibility Studies of Medical Devices
(As per ISO 10993, USFDA and EU MDR Guidelines)

Cytotoxicity Study (In-Vitro)
Sensitization Study (In-Vitro & In-Vivo)
Irritation or Intracutaneous Reactivity (In-Vitro & In-Vivo)

Preclinical & Toxicological Services
(As per OECD, NDCT, ICH, MHRA, USFDA/EPA Guidelines)

Acute Toxicity Studies (Oral, Dermal, Inhalation and Parenteral)
Eye/ Skin Irritation Studies
Skin Sensitization Studies (GPMT/ Buehler)

Phytochemical & AYUSH Testing Services
(As per AYUSH and other Guideline)

Description, Identification (Using TLC & HPLC/HPTLC)
Physico-chemical testing of Raw material and AYUSH formulations

Food Testing Services
(As per FSSAI, BIS, APEDA and EU Guideline)

Analysis of Food & Agricultural Products as per FSSAI, BIS, EIC/EIA, APEDA & European (EU) Standards
Analysis of Residual Pesticides, Drugs and Banned colorants in food products

Formulation & Development Services

Controlled release and Sustained Release Formulations
Excipient Compatibility Selection and Optimization
Formulation Development For New Chemical Entities (NCE)

Dyes, Pigment & Plastic Testing Services

Chemical testing of dyes & pigments of Textile & color Industry
Heavy metal Analysis
Particle Size Measurement

Research & Development Services (DSIR approved R & D centre)

Design & Development of Patent & Propriety Herbal Formulations.
Synthesis & process development of Pharmaceutical Herbal

Stability Testing Services

Accelerated and Real time stability testing of pharmaceuticals & chemicals as per ICH Guideline (ICH Q2R1)
All Zones Stability Testing are available including walk in stability chamber

Clinical Services

BA/BE Study of Drugs as per the Regulatory guidelines of the Particular country Specified by the Sponsor.
Clinical site management as per requirement by the sponsor.
Clinical Trial of Phase II, III and IV for Synthetic Drugs and Herbal Drugs as per schedule Y, ICMR and ICH-GCP guidelines

Regulatory Dossier Preparation

Preparation of CTD & e- CTD Dossier for countries like USA, Canada, Europe, Brazil.
Preparation of Dossier for Allopathic Formulations as well as Herbal Formulations also.

Accreditations

Accuprec Research Labs Pvt. Ltd. © 2024