Welcome to Premier MedTech Solutions
Customized Consulting & Risk Assessments for Pharma Compliance.
ICH M7 Compliance - Insilico Toxicity Predictions (QSAR), Risk Assessment and Control Strategies for mutagenic impurities (Class 1-5).
PDE)/ADE determination reports
Purge Assessments.
Expert Summary Report (QSAR) for Regulatory Submissions and to address query received from Regulatory Agencies.
Interpretation of QSAR Reports, to help in draft Expert Summary Report.
Support for issues related to Monograph related queries vs QSAR reports.
We offer complete End-to-End support - From Risk Assessments to Regulatory Responses.
Nitrosamine Risk Assessments and Mitigation Strategies
Nitrosamine Risk Assessments - QSAR Report
Health Authority Guidelines
Acceptable Intakes
Alternative approaches for Acceptable Intakes.
Risk Mitigation & Control Strategies.
Regulatory Submissions
Our Technical Team helps in filing submissions with Regulatory Agencies and support to address issues/concerns to queries raised by Agencies
Customized Onsite Training to R&D, QC, QA and Regulatory Affairs.
We offer an Onsite Full day Interactive Expert led Knowledge session to your Teams in R&D, QC, QA and Regulatory Affairs covering Regulatory Frameworks, Risk Assessments and Compliance Challenges related to ICH M7 & OECD 471 Guidelines.
Post Training Team Members gain insightful knowledge to address issues related to:
Mutagenic Impurities.
ICH M7 - Assessment & Control of DNA reactive (Mutagenic) impurities.
Implementation of ICH M7 Hazard Assessment & Risk Characterization.
Control Strategy for Mutagenic Impurities.
Purge Assessments.
Case Studies - Generic or Inhouse Chemical Compounds.
IT Consulting, Training and Support Services
Our IT consulting & Training Services help you maximize the value of your Technology investments. We offer a range of services, including Hardware, Cloud Migration, End-user Training in Software Tools to help the team to maximize knowledge in use of the implemented Technologies.
