Pharmatek Solutions offers comprehensive TMF Management services to ensure the quality, integrity, and regulatory compliance of your clinical trial records. Our experienced team of experts meticulously files all records in a timely manner to ensure inspection readiness and facilitates review of your TMF, identifying potential gaps, inconsistencies, and regulatory risks.
Our seasoned TMF experts possess in-depth knowledge of ICH GCP guidelines, FDA, EMA, and other global regulatory requirements. We proactively identify and address potential regulatory risks, safeguarding your organization from costly penalties and delays.
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Pharmatek Solutions Inc. is an integrated Validations, Clinical, and Quality business solutions provider to global life sciences companies.