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Lapis Quality Solutions
Our Services
Documentation
- Design and support for all QMS documentations
- SOPs & formats inline with current guideline requirements
- Specifications & Testing methods as per customer requirements
- Validations documentation - Process Validations, Cleaning Validations, Analytical method validations
- Documentation for Equipment & Instrumentation Qualifications
Regulatory Intelligence
- Compilation of DMFs, ASMFs, Dossiers for APIs, Drug Products as per CTD and ACTD formats for various markets like USFDA, Health Canada, EU, CEP for EDQM, TGA, emerging markets etc.
- Support for Regulatory submissions through eCTD Software to various Regulatory bodies
- Handling the regulatory deficiencies w.r.t. Regulatory filings and Regulatory audits.
- Deciding regulatory starting materials, specifications, impurity carry-over studies, Genotoxic impurities purge studies as per ICH M7, risk evaluation of nitrosamine impurities etc.
Audits
- Handling experience of successful Regulatory audits like USFDA / EDQM / TGA / CDSCO / COFPRIES/ Health Canada/ ANVISA/ DNV GL/ KFDA etc.
- Third Party Vendor audits
- Internal Audits & Assessment Audits (QMS gap analysis)
- Documentation & data review for data integrity issues
- Due diligence audit against submitted DMF / Dossier to verify the compliance
Comprehensive Training
- Trainings on QMS and ICH / 21 CFR / EUGMP guidelines
- Trainings on handling of regulatory inspection
- Trainings on regulatory updates to develop and maintain regulatory knowledge.