• Welcome To
    Synapse labs.com
15 Year Exerience
780+ BA/BE Studies
Successful Track Record Of Audits & Inspections
250+ Employees
Welcome to Synapse

Synapse Labs is a DCGI approved CRO(Contract Research Organization) based in Pune, India

Synapse Labs is a leading, independent Contract Research Organization (CRO) founded in 2007. We are offering comprehensive Bioavailability / Bioequivalence (BA/BE),Clinical Trial service,Pharmacovigilance and Regualtory Services to global pharmaceutical and biotechnology industry.

While leveraging on state-of-the-art facilities, we provide high quality, customized clinical research services with rapid turnaround time and at competitive price. Our experienced and GCP trained professionals contribute to the well-being of humanity by delivering quality research services in the process of drug development.

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Bioavailability /Bioequivalence Services.

Solutions for remedial proportionally between an pharmaceutical comparable product

Clinical & Experimental Pharmacology

Chemical Specifications and Bioavailablity

Bioanalytical Methods Development & Bioequivalence Studies

Clinical Trial Services

Experience on Major Therapeutic Indications.

Bioequivalence with Pk and Clinical End point Studies

Phase I/IIa/IIb/III/IV Trials

Database Mangement

NCE Molecule-IND, 505b(2) , ANDA Study Management.

FDA/PreIND MeetingSupport.

Pharmacovigilance Services

Safety Management

Clinical Pharmacovigilance, PMS Pharmacovigilance, Literature Automation/Literature Search, Aggregate/ Periodic Reporting, Signal Detection, Risk Management, Safety Data Exchange Agreements.

Medical Information Center

Medical Information/Database centers, Medical Enquires, Product Quality complaints, Standard /Customized Response Letters.

Medical Writing

Aggregate/Benefits/Risk Reports, Risk Management Plans, Safety Update Reports, Annual Updates, Medication Guides, Patient information leaflets

Automation and Technologies

Safety System Separate Database Environment, Electronic Submission , Automated Signal Detection System, Electronic Document Management, Data Migration.

Regulatory Services

CDSCO Application/ Approvals for Invitro/Invivo study conductions

Dossier Gap Analysis, Complete Dossier Writing, Dossier Support Services Translations (Smpc, PIL & Labelling), PIL User Testing, QP Audits, e-CTD Publishing, DMF, Dossier Maintenance and Labelling Maintenance,Dossier Variation Management.

Compliance on Warning Letters, Clinical Study Monitoring, GCP-GLP Audit Support.

Module e-CTD Compilations: Module 1- Module5, Complete Dossier Preparation

PreIND Meeting/ FDA Control correspondence

Regulatory Inspections/ Audits

DCGI (India), Inspection Date-27th Jul 2020 to 28th Jul 2020

USFDA, Inspection Date-17th Feb 2020 to 21st Feb 2020

NPRA (Malaysia), Inspection Date-11th Nov 2019 to 15th Nov 2019

MHRA, Inspection Date-03rd Dec 2018 to 07th Dec 2018

AEMPS (Spain) and Infarmed (Portuguese), Inspection Date-28th May 2018 to 30th May 2018

USFDA, Inspection Date-20th Nov 2017 to 24th Nov 2017

USFDA and AGES (Austria), Inspection Date-31st Jul 2017 to 02nd Aug 2017

ANSM (France) and AGES (Austria), Inspection Date-05th Jun 2017 to 09th Jun 2017

DCGI (India), Inspection Date-26th Oct 2016

USFDA, Inspection Date-13th Jun 2016 to 17th Jun 2016

USFDA, Inspection Date-23rd Mar 2015 to 27th Mar 2015

MHRA, Inspection Date-13th Oct 2014 to 17th Oct 2014

BfArM (Germany) and ANSM (France), Inspection Date-19th Feb 2013 to 22nd Feb 2013

ANSM (France), Inspection Date-26th Nov 2012 to 30th Nov 2012