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,
Facilities & Utilities Validation,
Process Validation and
Computer Systems Validation.
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:
Validation Summary Reports
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.
Controlled Rate Freezers,
-200 C Freezers 2-80 C Refrigerator Cold Rooms,
Environmental Walk-in Chambers,
Warehouse and Storage rooms.
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.
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.
Change control & CAPA management in Trackwise.
Data Center closure.
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.
AE /SAE Recommendation Letter.
Global Aggregate Reporting .
PADER PBRER PSUR’s.
Global Regulatory submissions.
Risk Management and CAPA.
Safety medical writing.
Medical Review Services.
E2B safety Data Exchange.
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.
Data Entry and Backup .
Data Cleansing and Query Management.
Dictionary coding using WHODD, MedDRA.
Integration, Verification, Validation and & Reconstruction of Electronic Data.
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...
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:
Clinical Research Co- Ordinators.
Clinical Research Scientists.
Clinical Trial Monitors.
Clinical Trial Managers.
Clinical and Post Marketing Pharmacovigilance Experts.
Regulatory Submission specialists.
Regulatory labeling Specialists.
Healthcare IT Experts and IT Professionals.
Excellent safety team with 500 yrs of Cumulative experience.
LOW cost and High Efficiency out come.
Reliable time lines.