Projects ( Pharma, Biopharma, API )
Greenfield / revamping facility
Project Report and Business plan
Project documents ( URB, URS, Room Book, Flowsheets, Change Control, Gap Analysis etc.)
Layout designing support
Project Validation (VMP, DQ, IQ, OQ,PQMP, PQ,PQR, PVR,CLIA, SLIA, etc.)
Regulatory & Compliance (Pharma, Biopharma, API, Food)
USFDA Remediation and Audit Compliances
Batch Record Review/ Data Integrity/ Electronic Data Review
Preparation for FDA Pre-approval inspections (PAIs)
Pre Audit Support
Third Party Audit
Quality System development
DMF(CTD), CMC and Dossier Preparation
Validation (Pharmaceuticals,Food, IT, Engineering, Automobile etc.)
Computer System/Software Validation/Audit Trail
SPL, eCTD, SCADA, ERP / SAP validation
Cleaning Validation/Process Validation
Media fill validation ( barrier or without barrier)
Analytical Method Validation
Equipment / Utilities Qualification
Utility Qualification/ HVAC
Environment Monitoring
Micro / Biological testing
Technical Documentation
CAPA, Deviations, Change Control
Risk Analysis, HACCP, FTE, FMEA
SOP, Validation Protocol and Template
Validation Data Review and Report Preparation
QA, QC documentation
Site Master File
Quality Manual
Safety Manual
Training Manual
Gowning Manual
ISO documentation / Certification Support
Training Programs with visual aid/ film
GMP & GLP
Validations
Aseptic Maintenance
Media Fill
Greenfield Project
Disinfection & Hygiene Service
This is the special kind of disinfecting & hygiene service which is different from regular pest control or sanitation programe. This assures entire removal of micro organisms and viruses. Our personalise tips help our clients; refrain from communicable disease.
This services is recommended for Residential Houses, Commercial Complexes, Schools, Hospitals, Hotels, Hostels, Commercial & Private vehicles and other public areas susceptible to contagious diseases.
Provide Technical Staff
BCS provides Technical staff for recruitment as per the requirement and availibility, without any charges to any employer as well as employee.
GMP-Validation-Audit-Training................
Process equipments, Testing Instruments, Packing equipments; Gap Analysis, Risk Analysis; CAPA, CLIA, SLIA, Risk Analysis; HACCP, FMEA, Process Validation, Method Validation; Aseptic Operations; Computerised System Validation, SCADA Validation; Cold Chain Validation; Shipment Validation; Betalactum contamination Validation; Aseptic Equipment Maintenance; Boilers, chillers, heat exchangers, cold rooms, DG validation, Reactors, filters, rotavapours, lyophilizers validation; EM Validation; Tabs/ Capsule Machines; AAT,ACS,BMS, Steriliaers, LAF, Cold chain, Audit trail validation
