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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.

Analytical Testing

  • Analytical Testing Of Pharmaceuticals & Cosmetics
  • API characterization and analysis
  • Analytical method development
  • Bio-Analytical Method Development and Validation
  • Comparative Dissolution Study
  • Impurity Isolation and Characterization
  • Method Validation as per ICH and USP guideline
  • Excipient compatibility Study

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Biotechnological Services

  • Cell-Line Study for New Molecules
  • Determination of Immunoglobulin using HPLC
  • ELISA Testing
  • In-Vitro Cytotoxicity Study
  • Qualitative and Quantitative Testing of Protein (SDS-Page, Native Page)
  • Qualitative and Quantitative Testing of Nuclease
  • Contamination (DNase and Rnase )
  • Testing of Human DNA Contamination
  • Testing of Host Cell DNA
  • Testing Using RT – PCR

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Microbiological Services

  • Antibiotic Assays
  • Assay of Vitamins
  • Bio- Burden Testing
  • Identification and Characterization of Microorganism
  • Microbiological Testing of Formulation
  • Microbial Limit Test (MLT)
  • Pathogen Identification
  • Sterility Testing
  • Testing of Bacterial Endotoxin (LAL Test)
  • Validation of Microbial Test Methods

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Bio - Compatibility Studies of Medical Devices
(As per ISO 10993, USFDA and MHLW Guideline)

  • Cytotoxicity Study
  • Genotoxicity
  • Hemocompatibility Study
  • Implantation Study
  • Irritation or Intracutaneous Reactivity
  • Systemic Toxicity Study (Acute)
  • Systemic Toxicity Study (Sub - Chronic)
  • Sensitization Study
  • Degradation & Toxicokinetic Study

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Preclinical & Toxicological Services

  • Anti Cancer Activity (In - Vitro/ In Vivo)
  • Anti HIV Activity
  • Bio - Analytical Study
  • CNS, CVS, Antidiabetic Activity, Anti obesity Activity
  • Customized Screening of Services
  • Development of Animal Screening Models
  • DMPK Study
  • Pyrogen Testing
  • Screening of Analgesic, Anti - Inflammatory and Anti - Arthritic Activity
  • Toxicological Studies
    (As per OECD and Schedule Y Guidelines)

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Phytochemical Services

  • Development of Herbal Formulations
  • Determination of Heavy Metals and Microbial Contamination
  • Extraction, Fractionation and Otpimization
  • Estimation of Phytochemical
  • Isolation & Characterization
  • Standardization of Herbal as well as Ayurvedic Medicines
  • Validation of Ayurvedic Medicine

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Food Testing Services

  • 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
  • Contract Testing Services to Support your HACCP, ISO, GMP and GLP Compliance
  • Fatty Acids composition and trans fat content
  • Mycototoxins B1, B2, G1, G2, M1 and Ochratoxin in various matrices.
  • Proximate analysis and nutritional labeling of food products
  • Shelf life estimation of packed food

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Formulation & Development Services

  • Controlled release and Sustained Release Formulations
  • Excipient Compatibility Selection and Optimization
  • Formulation Development For New Chemical Entities (NCE)
  • Lab Scale, Pilot Plant, Scale Up Production
  • Novel Drug Delivery System for Existing Drugs
  • Optimization of Existing Formulations
  • Tech Transfer and Commercial Production Support

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Dyes & Pigment Testing Services

  • Chemical testing of dyes & pigments of Textile & color Industry.
  • Heavy metal Analysis
  • Particle Size Measurement
  • Particle Size Volume Determination

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Herbal Formulation Development

  • Design & Development of Patent & Propriety Herbal Formulations.
  • Optimization & validation of Formulation at Lab Scale.
  • Technology transfer for commercial Production.

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Stability Testing Services

  • All Zones Stability Testing are available
  • Determination of Shelf life of Medical Device & Disposables
  • Stability Testing as per ICH Guideline

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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
  • Preparation of Clinical trial Protocol for Synthetic Drug and as well as Herbal Drug and Regulatory Approval there of

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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.

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IP Management Services

  • Patent Search, Drafting & Filling
  • Trademark Search & Filling Services
  • Industrial Design Search & Filling Services
  • Copyright Filling Services
  • PCT Application Drafting & Filling
  • Patent Prosecution with patent office of India
  • IP Valuation & its Management
  • Technology transfer & Licence agreements

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