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Corporate Presentation CliniApps Private Limited True Calibration Services

www.cliniapps.com www.truecal.in

For, us quality means taking over responsibilities in all areas. The offer of high quality services and a constant strive for improvement represent our core objectives. All employees focus on achieving these objectives.

CliniApps Private Limited and True Calibration Services is certified according to the ISO 9001:2015, ISO 17100:2015 and NABL Accredited Calibration Laboratory and represents an independent organization who support the CRO, SMO Pharmaceuticals, Laboratory, Medical device organization and health care sector.

ABOUT US

CliniApps Private Limited and True Calibration Services was founded in 2012 by technocrats from leading Indian Pharma and CRO.

Our experienced and committed team of experts will offer you individual solutions for your business.

Our Company

Our expertise combined with many years of experience is the basis for our company’s philosophy and success.

Language Translation

Monitoring, Auditing

CRO Setup Services

BA Lab Set Up

Services

GCP, GLP Training

Bioanalytical Services

Our Services

Instrument Calibration / Mapping

Instrument Validation / IQ, OQ, PQ

Our Strenghts Experience Flexibility Motivation Individuality Continuity Adherence to schedules High levels of professional

and social competence Efficient and Target

oriented working Quality Management System

Our Team Project-oriented and efficient working methods, accuracy, reliability and global and cross-linked thinking are just some characteristics of our team. These are decisive factors for a successful project handling.

The know-how and commitment of our employees are crucial for the success of our company. Therefore, continuous education and training ensure that their knowledge and skills are always up to date.

Take advantage of our experience and our flexibility in order to increase your resources with the help of our team.

Our Leadership

Mr. Paras Shah CEO

Mr. Darshit Shah Head – BD &

Strategy

Mr. Shailendra Gupta Head - Bioanalytical

Mr. Ambrish Nakum Head -

True Calibration Services

Language Translation Service

CliniApps Translation Offers multiple level of translation Services based on clients needs ranging from draft /summary translation upto certified translation, featuring our multiple – step translation and review process to ensure the highest level of accuracy and meet the evolving needs of Global business

Recent Highlights of Language Translation @ CliniApps

ISO 9001 : 2015 – Quality Management Services

ISO 17100 : 2015 - Translation Service Requirements

Recently passed 03 MNC’s Audit with “No Observation”

Year 2018, passed 07 audits from the different CRO’s and Pharmaceuticals

Language Translation Service D

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Package Insert

IB

Protocols

ICF’s / ICD’S

PDC / Materials

SOP’s

NDA and IND

IP Labels

Regulatory Audit

AE / SAE

Dossiers

Website Translation

Drug Registration

Leaflet Translation

Product Labels

Manufacturing Data

Master Batch Records and Deviation Reports

Marketing Manuals

Production Manuals

Regulatory Responses

Instructions for Use (IFU)

Contracts

AE / SAE Document

Scientific Journal Articles

Data Sheet

SOP’s

Patient Reported Outcomes (PRO)

Questionnaires

Regulatory Documents

Source Documents

Literature Translation

Pharma PV Clinical Research

Language Translation Service

Indian Languages Assamese / Bengali / Gujarati / Hindi / Kannada / Kashmiri / Konkani / Maithili / Manipuri / Marathi / Nepali / Oriya / Punjabi / Sanskrit / Santhali / Sindhi / Tamil / Telugu / Urdu

African Languages Arabic / Swahili / Zulu / Afrikaans / Amharic / Somali / Rwanda-Rundi / Shona/ Luo / Kongo / Tigrinya

American Languages English / Spanish / French / Portuguese / Dutch

Asian Languages Pashto / Armenian / Arabic / Bhutanese / Malay / Chinese / Greek / Turkish / Georgian / Hindi / Urdu / Bengali / Bahasa Indonesia / Persian / Hebrew / Japanese / Korean / Burmese / Nepali / Thai / Turkish / Uzbek / Vietnamese

European Languages Albanian / German / Russian / Bosnian / Bulgarian / Greek / Czech / Danish / Estonian / Danish / Finnish / French / Hungarian / Icelandic / Irish / Italian / Lithuanian / Maltese / Norwegian / Polish / Romanian / Serbian / Slovak / Ukrainian / Latin

GCP / GLP Training

We offer an extensive range of training which include the following

GCP Training Introduction to GCP Monitoring and Auditing Clinical

Laboratories GCP Compliance for Monitors / Ethics

Committee Advanced Quality Assurance Good Clinical Laboratory Practice (GCLP)

GLP Training

GLP Training for Test Facility Management GLP Training for Study Directors and study staff Conduct of Multi-site studies in compliance with GLP Advanced Quality Assurance Implementing GLP in your Company Advanced GLP (the real issues) GLP in the Laboratory Good Clinical Laboratory Pratice (GCLP) training for

organizations and laboratories which process and analyse samples from Clinical Trials.

Clinical Monitoring

Site Initiation Visit includes :-

Advance Evaluation and resolution in Protocol/ICF/CRF & other documents.

Gives an opportunity to site /CRO to be ready Practical issue resolution well before study initiation Evaluation of capabilities of Site staff & Vendors Advance query resolution in terms of regulatory

requirements Resolution of Safety issues

Original and Transparent view of your project at your desk

Interim projects updated including subject enrollment, dosing, unexpected AE/SAE or withdrawal etc.

Informed Consent Presentation, Volunteer’s Recruitment, Process and evaluation of Cross-Participation Process

Pharmacy Procedure Reporting of AE / SAE / Withdrawal Compliance to regulatory, Protocol and in-house SOPs. Staff Training Documents Instrument Calibration / Validation

Site Monitoring Visit includes :-

Clinical Monitoring

Site Closeout Visit includes :-

CAPA Procedure

AE / SAE Reporting

IMP Accountability after completion of study

Sample storage requirements and accountability.

Draft report review along with source data review to ensure

appropriate transcriptions.

Retrospective Monitoring Visit includes :-

Conducted after completion of Clinical Phase

and/or when the draft report is ready.

To ensure error free reporting

Complete source data review allows

reporting and resolution of any error before

submitting as a report

Bioanalytical Monitoring

In process Bioanalytical Monitoring Visit includes :-

Accuracy in initial experiments before start of analysis

The error- free stock weighing, CC/QC Preparation, Spiking, Storage

and accountability of CC/QC.

Accurate solution preparation.

Total accountability of study sample receipt and storage.

Processing of study samples according to Method SOP

Calibration status before use of instruments

Retrospective Bioanalytical Monitoring Visit includes :-

All the raw data check, samples review

Instrumentation review,

All study data including draft Bioanalytical Report review.

Draft BA report verification against all the raw data.

Bioanalytical Monitoring

Pre-study Method Development and Validation (MD/MV)

To ensure that Method Development is done with sufficient numbers of trials to come to accurate method.

To ensure that right interference and inference is drawn from the developed method.

Ensures that method is validated as per regulatory requirements without missing any critical experiment.

To have the confidence that developed method is robust enough to avoid any issue in study sample analysis.

Risk Based Monitoring Approach Due to regulatory changes in clinical trials, such as the introduction of the

addendum to the ICH GCP E6(R2), new FDA guidelines for industry on risk-based monitoring (RBM), and the European Medicines Agency’s (EMA) reflection paper on risk-based quality management, the urgency of the RBM process implementation has increased in most biopharma establishments.

CliniApps has well defined SOPs for conduct of Risk Based Monitoring (RMB) of

Clinical and Bioanalytical Phase.

Audits Which We Cover

Audits

QMS Audit

Root Cause Audit

GAP Audit

Vendor Audit

Pre-inspection

Sponsored Audits

BA Method Development Services

Total and Free Drug Analysis

Multiple Analytes 2,3,4 or 5

Derivatization Method

Handling of Unstable Molecule

Very Low Detection (Around 1pg / ml)

Analysis of Vitamin (D3, K)

Total and Free Drug Analysis

Chromatographic method of Glauconite

Hormones Chiral Method

Isomer Investigation Bisphosphonates

Our experienced team has decades of bioanalytical method development and LC/MS/MS experience. Our scientists are capable of rapidly solving complex bioanalytical problems by utilizing leading edge technology and state-of- the- art techniques. We develop and validate robust quantitative bioanalytical methods in numerous biological matrices including whole blood, plasma, urine, other fluids and tissues.

Instrument Calibration, Validation and Mapping

NABL Accredited Calibration Services includes (Thermal, Mechanical & Electro Technical

Calibration)

Validation Services includes (DQ / IQ / OQ / PQ )

Mapping Services includes

( Temperature Mapping Services)

List of Instrument which we can do Calibration, Validation and Mapping

Temperature And Humidity Calibration

Thermal Calibration

Mechanical Parameter

Volumetric Calibration

Dimensional Metrology Calibration

Mass Calibration

Speed Calibration

Time and Frequency Parameter

HVAC & Clean Room Validation

Alco Sensor Calibration

Glucometer Calibration

Glassware Calibration

Calculator Calibration

If you are selling Your instruments in

INDIA than we are best for

Calibration / Validation / Mapping / HVAC / Clean Room

Validation and Maintenance

CliniApps Private Limited

True Calibration Services (A Unit of CPL)

A-102, Oxford Avenue, Nr. Income Tax Circle,

Opp. C.U. Shah College, Post Navjivan,

Ahmedabad - 380014, Gujarat, India

Mr. Darshit Shah; +91-99250 01790; darshit@cliniapps.com

Mr. Paras Shah; +91-9909125620 ; paras@cliniapps.com

Telefax : +91-79-27542161

Web-site : www.cliniapps.com Web-site: www.truecal.in

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