QA & Regulatory

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QA & Regulatory Services:


QA & Regulatory

Medzus healthcare staff will assist you on each critical process of clinical & pharmaceutical QA & Regulatoryadmission. Also provide you better service through the experienced personalities by following ways.

Quality Assurance:

The auditors at Medzus are assigned to your project from its initiation and full compliance is assured through in-life, in-process, protocol, data, documentation and report audits conducted on every study or project. Our standard operating procedures (SOPs), test methods and training documentation are all issued and maintained under strict document control by our quality assurance group. Our team and processes assure regulatory compliance with FDA, guidelines that include but are not limited to GLPs, cGMPs and specifically ICH Q7 guidelines.

Throughout the progress of your study, all documents/data are archived to assure complete and accurate documentation in addition to the retention to regulatory requirements. All validation/qualification programs are coordinated through validation specialists on our team in conjunction with the operational divisions and the corporate computer validation committee.

While our focus and dedication for our quality assurance staff is internally driven, the associates are available for consulting audits.

Audit of Critical Documents:
Protocol, IB, CRF, ICD, Clinical Report Audits against client SOPs and ICH GCP requirements.

Audits of Final Study Reports/NDA submissions/Safety Reports/IND updates-audits of database in comparison to reports/submissions to RA or other governmental authorities

Regulatory Affairs:

We provide regulatory services to facilitate all stages (Phases I-IV) of drug development. Our ability to dealing with complexities of all regulations and assist the sponsors to obtain regulatory approvals. We also assist you for getting regulatory approvals of foreign molecules in the fastest possible time.

Regulatory specialists to assist our clients with regulatory issues in India for drug & devices. Some of our speciality services are:

  • Regulatory and strategic consultation for early stage of drug development
  • Preparation of Chemistry, Manufacturing and Control (CMC) and Toxicology/Pharmacology regulatory submissions (eCTD Format)
  • Consultation, representation and coordination of pre-IND (PIND) meetings with FDA
  • Regulatory preparation and consultation for IND submissions
  • Chemistry, Manufacturing and Control (CMC) changes, process optimization, technology transfers and/or validation planning
  • Regulatory approvals for conducting BA/BE studies
  • Product registration for marketing approval
  • Approval for import /export of supplies
  • Drug & Device registration
  • Clinical Trial approval from Drug Controller Government of India (DCGI).