iPharmatec Solutions (IPTS) is a fast-growing international consultancy offering cGMP compliance, risk based commissioning, qualification and validation (CQV), computer system validation and engineering consulting services to pharmaceutical, bio-pharmaceutical and medical device industries.
We provide our clients with a competitive advantage by helping them build, commission and operate manufacturing facilities that comply with International cGMP regulations.
Services at a glance:
Project Commissioning, Qualification and Validation (CQV) Execution and Management
COMPUTER SYSTEM VALIDATION: PLC, HMI, SCADA, Automation System, LIMS, ERP, MES, SAP Validation Field Execution (21CFR part 11, Annex 11, GAMP5)
TEMPERATURE MAPPING: Warehouse, Autoclaves, Sterilizers, Dry Heat Sterilizer, Ovens, Incubators, Cold rooms Temperature Mapping
Cleanroon and HVAC Qualification
ISOLATOR | CONTAINMENT SYSTEM VALIDATION
- End to End implementation of Risk based Validation / Qualification System
- Facility Risk Assessment {FMEA, HAZOP, HACCP, FTA etc.}
- Risk-based Cleaning, Process Validation
- Validation Protocols / Reports (URS, EDS, RA, DQ, FAT, SAT, IQ, OQ, PQ)
- Suppliers Audits
GMP COMPLIANCE SERVICES:
- System based GMP Audit -> Gap Analysis -> Recommendations -> Implementation with respect to facility, utilities, process equipment, lab instruments, computer systems and quality management system
FACILITY CONCEPT DESIGNS, BASIC AND DETAILED ENGINEERING SERVICES
- Facility cGMP Design Gap Analysis
- Facility revamp and Modernization
MEDICAL DEVICES REGULATORY SUBMISSION SERVICES
- Medical device complete technical documentation including Software File (IEC 62304), Risk Management File (ISO 14971), Usability File (IEC 62366-1), Safety and Essential Performance File (IEC 60601-1) etc.
GMP TRAININGS SERVICES
- GMP e-Modules, GMP Books
Contact us:
+91 9599579585
info@ipharmatecsolutions.com
ipharmatecsolutions@gmail.com
Company Details
- Employees
- 9
- Founded
- -
- Address
- Sahajeevan, 1102, 11th Floor, Rokadia Cross Lane, Opp Se International School, Svp Road,, Mumbai,mumbai 400092,india
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- ipharmatecsolutions.com
- Keywords
- GMP Compliance, Quality Compliance, Qualification, Validation, GMP Consulting, Risk Management, Quality by Design, Pharma Engineering, Risk Assessment (FMEA), Performance Qualification, Process Validation, Computer System Validation, PLC, SCADA Validation, Regulatory Affairs, 3D Facility View, QMS Establishment, regulatory.
- HQ
- Mumbai, Mumbai
Ipharmatec Solutions Questions
Ipharmatec Solutions's website is ipharmatecsolutions.com
Ipharmatec Solutions's LinkedIn profile is https://in.linkedin.com/company/ipharmatec-solutions
Ipharmatec Solutions has
9 employees.
View email and phone details for 9
employees at Ipharmatec Solutions.
Ipharmatec Solutions's industry is
Pharmaceutical Manufacturing
Ipharmatec Solutions's top competitors are
Orbedge Solution Pvt Ltd,
Instrumentation And Control Solutions,
Scinotive,
Clardes Eng Consultant,
Helixdna Technologies,
Indomtech Development,
S Kins Pharma,
Magnatte Lims,
Aigle Biosolutions Private Limited,
Ignitive Lims.
Ipharmatec Solutions's categories are Pharmaceutical Manufacturing
Ipharmatec Solutions's founding year is 2017
