Services
Comprehensive Regulatory & Compliance Services
Empowering life sciences organizations with end-to-end solutions in regulatory affairs, Pharma-IT, validation, and quality systems to ensure compliance and sustainable growth.
Excellence in Regulatory, Compliance & Process Development Support
Delivering specialized regulatory, compliance, and validation solutions across the life sciences and pharmaceutical sectors.
Computer System Validation (CSV) C& Q Projects
CSV consulting and onsite execution for COTS Cat-3, Configurable enterprise systems Cat-4 and Cat-5 systems like QMS, LMS, ERP, LIMS, Lab Systems, eLN, SaaS, PLC etc.
Commission of facility/ cleanroom and product process systems like filling line, mixing vessel etc.
Pharma Software Development
Assistance in development of enterprise software product as per your business requirements and regulatory compliances.
Customization and develop software forpharma companies.
Regulatory Support
FDA(XLN System): Firm Registration and Licensing, Certificates, Approvals.
CDSCO / DCGI registration and product permission.
DossierCompilation. CTD Format -Module 1 to Module 5
WHO- GMPapplication, COPPapplication.
MPCB Support
Online registration, Consent Application (Establish/ Operate/ Renewal)
Hazardous Return File (Form 4), Environmental Statement file (Form 5)
ETP& STPPlant setup with ZLD concept, Legal Compliance
Document Development
QMS and all level Organizational documentation.
SOPs, Policies, Plans, Reports etc. as perGood Documentation Practices (GDP).
Auditing Services
Facilitate internal audit to mitigate non-conformities.
Internal and External Audit Program- GMP& ISO 9001:2015.
