OurValidation Services

We are specialized in Validation services, our customers includes Pharmaceutical, Bio-tech industry. Our Validation team travels across the globe and is capable of supporting small to large scale validation projects.Our Validation Services includes but not limited to;

Equipment & Instrument Qualification,

Cleaning Validation,

Facilities & Utilities Validation,

Process Validation and

Computer Systems Validation.

Equipment & Instrument Qualification

Our team of expert validation engineers will provide validation documentation with quality and accuracy. Our team provides support on validation documentation such as protocols, reports and SOP templates as per FDA/EU and other regulatory guidelines for manufacturing and process equipment including Bioreactors, Process vessels, Autoclaves, lyophilizers and Purification skids etc and Control Temperature Units such as Freezers, Refrigerators, Incubators, Ovens, Walk-in Cold rooms etc. Environmental Monitoring of Clean rooms, Manufacturing and process areas etc.

Qualification Protocols includes:

Installation Qualification.


Operation Qualification.


Performance Qualification.


Instrument/Equipment Calibration.


Validation Summary Reports


Cleaning Validation

United Pharma Technologies a dedicated consulting services helping Pharmaceutical, biotechnology companies through our GXP Compliance and consulting services. United Pharma Technologies offers full spectrum of validation services which includes but are not limited to Cleaning validation, Temperature Mapping. Our qualified validation specialists have the necessary expertise to develop and improve your cleaning validation methods, procedures and provide you with clear expectations and deliverables for each step and, of course, customize each process to meet your unique requirements. Our expert staff provides services in Commissioning, Qualification includes but not limited to Design reviews, SAT’s, FAT’s Commissioning Protocols, Checklists, Line and Tank OQ and PQ development, execution, Summary reports, URS, FRS, Risk Assessments, SOP, Protocol generation, Exceptional Condition/Deviation/Investigation Management, Spray Coverage testing, Unsoiled and Soiled Cycle Development studies, Confined Space Entry, Lock Out Tag Out, Swab and Rinse Sampling of CIP Skids, Vessels, COP Washers. Our specialists work very closely with manufacturing, QC, engineering, facilities to ensure compliance of cGMP systems with all internal Quality requirements. Our expert staff will provide world-class Thermal Validation services. United Pharma technologies use Industry Standard Kaye and LIVES data Loggers for Thermal Validation projects. All test equipment’s used for the execution of thermal validation studies will be certified and calibrated to NIST traceable standards.

Capabilities/Expertise:

LN2 Tanks.

Cryopods,

Controlled Rate Freezers,

Low Freezer,

-200 C Freezers 2-80 C Refrigerator Cold Rooms,

Environmental Walk-in Chambers,

CO2 Incubators,

Warehouse and Storage rooms.

Facility & Utility Qualification

Our Facility and Utility Validation services provides qualification of following:

HVAC and Air Handling Units.

Water For Injection (WFI), USP Water.

Compressed Air and Gases, Clean Steam.

Computer Systems Validation:

At United Pharma Technologies, we provide Computer System Validation services managing software implementation until its Go-live. We ensure to follow the GMP, GCP, GLP, GDP,GAMP 4&5,21 CFR Part 11 FDA regulations and EU Annex 11 guidelines throughout the project. We specialize in Software Development Life Cycle (SDLC) which includes Concept development, Planning, Design&Development, Verification, Operation and Retirement. Our expertise extends.

Data Integrity & Remediation.

Ad-hoc reporting.

Periodic reviews.

Change control & CAPA management in Trackwise.

Data Center closure.

Pharmacovigilance Services:

We Provide Complete End to End Pharmacovigilance Services from Data Entry to Regulatory Submissions. We specialize in Pre-Clinical and Post Marketing cases including AE, SAE, Initial Receipt, case processing, follow-up, medical review and case closure.

Our PV Services Includes.

Data Entry.

Case Processing.

AE /SAE Recommendation Letter.

Global Aggregate Reporting .

PADER PBRER PSUR’s.

Signal Detection.

Global Regulatory submissions.

Risk Management and CAPA.

Safety medical writing.

Medical Review Services.

E2B safety Data Exchange.

Clinical Data Management Services:

United Pharma Technologies is specialized in Clinical Data Management and statistical services, Our Team is exceptional in Good Clinical Data management practices, We provide Design Build and Deploy Clinical Trial Databases. We at United Pharma provide End to End CDM Services from Pre Clinical to Post Marketing Trials.At UPT we ensure you the quality of trials From Trial Setup, Database Design to Database Locks.

OUR DM Services Includes:

DaCRF /eCRF Design.

Database Design Build and Deployment.

DMP Development.

Data Entry and Backup .

Data Migration.

Data Review.

Data Cleansing and Query Management.

Dictionary coding using WHODD, MedDRA.

Integration, Verification, Validation and & Reconstruction of Electronic Data.

Database Lock.

DB Transport.

Application Development.

United Pharma Technologies Solutions application development services help you address evolving business and technology challenges by defining, designing and building applications tailored to meet your business requirements. We deliver high-quality, flexible applications that are easy to maintain; modular to facilitate enhancements and are reliable, secure and easy to deploy using the Global Delivery Model. It is based on industry standard process quality frameworks (CMMi, CMM, etc.) and uses rigorous methodologies and the expertise of our Centers of Excellence to mitigate risk and deliver cost and time-to-market benefits...

Professional Services:

UPT is a leading player in the Pharma/Pharma professional services industry offers full lifecycle permanent professional services services to organizations. UPT helps with permanent Pharma/Pharma professional services needs by providing 24 x 7 access to a diverse pool of highly talented and experienced software professionals to meet the strategic and long term requirements of organizations.

United Pharma Technologies Inc. provides a diligent recruiting solutions for end to end life sciences fields includes:

Chemists.

Research scientists.

Statisticians.

Clinical Research Co- Ordinators.

Clinical Research Scientists.

Clinical Trial Monitors.

Clinical Trial Managers.

Data Managers.

SAS Experts.

Clinical and Post Marketing Pharmacovigilance Experts.

Validation Experts.

Regulatory Submission specialists.

Regulatory labeling Specialists.

Regulatory Managers.

Healthcare IT Experts and IT Professionals.

United Pharma Technologies promises:

Excellent safety team with 500 yrs of Cumulative experience.

LOW cost and High Efficiency out come.

Reliable time lines.