SERVICES OFFERED
Giving Directions to achieve highest quality
PROJECT MANAGEMENT
Complete support for erecting Pharmaceutical and Biotech Manufacturing Facility. Plant layout designing for Sterile and Non Sterile facilities like Tablets, Capsules, Injectable, Vaccine, API and R&D Labs as per International CGMP norms and Project Execution support including designing HVAC, Water Systems, Project monitoring etc.
QUALITY SYSTEMS
Designing and revamping of QMS for Tablets, Capsules, Injectable, Biotech and API facilities to meet national and international regulatory requirements and expectations like WHO, FDA, MHRA, PICs norms.
QUALIFICATIONS AND VALIDATIONS
Facility Qualification and Validation including Utilities like Water System, HVAC, Instruments, Equipment, Process Validation, Cleaning Validation, CSV, Analytical Method Validation, etc.
THIRD PARTY AUDITS/ GAP ANALYSIS AUDITS
Perform audits of Facilities against Schedule M and global requirements as per EU, PIC/S, MHRA, US FDA and other international regulatory requirements, GAP Analysis of Laboratory against Schedule L1.
AUDIT PREPARATION SUPPORT
Futurol Enterprises team is providing complete support for Audit preparation, Audit Response, compliance and remediation activities
DOCUMENTATION
Preparation of documents like VMP, SMF, SOPs, URS, DQ, IQ, OQ, PQ, PVP/PVR, SOPs, SMF etc. as per regulatory requirements.
QUALITY CONTROL
Designing and qualification of Quality Control Laboratories as per international regulatory requirement.
TRAININGS
GMP, GLP and QMS Trainings to develop knowledgeable workforce
GMP COMPLIANCE ADVICE
Simple and cost effective compliance solutions
REGULATORY
DCGI and FDA Communications, Dossier preparation etc.
EQUIPMENT
Selection of equipment for new and old projects.
PROCESS IMPROVEMENT
Process Standardization, Yield Improvement, Troubleshooting.
ASEPTIC SOLUTION
Effective Media Fill and improvement of aseptic practices
FORMULATION DEVELOPMENT AND TECHNOLOGY TRANSFERS
Expert Guidance
TROUBLESHOOTING
Troubleshooting for Product Stability, Sterility failures, Microbial contaminations, OOS, OOT etc.