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Page 1: Zydus Gujarat, India. +91 90996 16769 | +91 99099 19545 ... Brochure @ Accuprec... · • Controlled release and Sustained Release Formulations • Excipient Compatibility Selection

ZydusGujarat, India.

Scan QR Codefor More Details

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+91 90996 16769 | +91 99099 19545 | +91 90999 81023

Page 2: Zydus Gujarat, India. +91 90996 16769 | +91 99099 19545 ... Brochure @ Accuprec... · • Controlled release and Sustained Release Formulations • Excipient Compatibility Selection

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

• 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

1) Analytical Testing Of Pharmaceuticals & Cosmetics

• 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

2) Biotechnological Services

3) Microbiological Services

Dr. Rina Gokani (Director & CSO)

To become catalyst for ours client’s growth by means of conversion from “Research to Revenue”.

AIM

VISION

Shri Mulubhai Kandoriya (MD)

MISSION

“Uncompromised quality and prompt service”

MOTTO

Accuprec Research Labs Pvt. Ltd. is a Service provider for various testing services required for pharmaceuticals, chemicals, phytochemicals, food product, herbal formulations as well as Medical devices. Accuprec has been founded by a group of highly qualified professionals having excellent track record with proven success and commitment to quality in their respective areas of expertise.

Currently we are working with 200+ companies of Pharma, Food & Medical device Manufacturers from India and outside India.

Dr. Manish A. Rachchh (Director & CEO)

Mr. Mayur Kandoriya(Director & CMO)

(1709/PO/Rc/S/13/CPCSEA)

NABL Accredited(TC-6124)

4) 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 StudyISO 9001:2015 Cer�fied(ASCB‐UK, 2017‐HK‐0010)

S

GLP Certified

Page 3: Zydus Gujarat, India. +91 90996 16769 | +91 99099 19545 ... Brochure @ Accuprec... · • Controlled release and Sustained Release Formulations • Excipient Compatibility Selection

• 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

8) Formulation & Development Services

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

9) Dyes & Pigment Testing Services6) 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

• 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)

5) Preclinical & Toxicological 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

7) Food Testing Services

• Design & Development of Patent & Propriety Herbal

Formulations.

• Optimization & validation of Formulation at Lab Scale.

• Technology transfer for commercial Production.

10) Herbal Formulation Development

Page 4: Zydus Gujarat, India. +91 90996 16769 | +91 99099 19545 ... Brochure @ Accuprec... · • Controlled release and Sustained Release Formulations • Excipient Compatibility Selection

• 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

12) Clinical Services

11) Stability Testing Services

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

13) 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.

14) 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.

Out Reach of Accuprec

Board of Advisors

Na�onal Start Up Summit(Mahatma Mandir,

Gandhinagar, Sept 2016)

th7 Pharmac‐India 2016(GU Conven�on Center, Ahmedabad, Oct 2016)

th7 World Ayurvedic Congress 2016(Science City,

Kolkata, Dec 2016)

th14 IMDI

Conference(AMA, Ahmedabad

March‐2017)

iPHAX 2017(Hyderabad, April 2017)

Vibrant Gujarat 2017(Gandhinagar, January 2017)

Vibrant Gujarat‐2015(JAN ‐ 2015)

Bangalore India Bio

(Feb‐ 2016)

th13 IMDI Conference,

AMA, Ahmedabad (Feb 2016)

Na�onal Food & Pharma Summit 2017

(Ahmedabad, August 2017)

Mr. Padmin BuchIPR expert and Former MD,

Gujarat Industrial and Technical Consultancy Organisation Limited (GITCO)

Prof. (Dr) Navin ShethVice Chancellor,

Gujarat Technological University

Dr. S.P. Adesara Former Commissioner,

FDCA, Gujarat

Dr. Jaimin Vasa Senior Vice President,

Gujarat Chamber of Commerce and Industries

Mr. Rajiv Mehta President, Ahmedabad

Management Association

Dr. Mukesh Gohel Former Principal,

L.M. College of Pharmacy

Mr. Anil Pandey, Head, IP Facilitation

Centre at CII, Ahmedabad

Mr. V.P. Mehta, Chartered Accountant,

Jamnagar

Prof. Vasu AppannaLaurentian University,

Canada