semlerresearch

Part of US based
Semler Group of Companies,
in business since 1946

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Quality Assurance

Semler Research Center (SRC) strives to provide our sponsors superior quality services that meet the highest standards of professional performance by ensuring that our products and services comply with all regulatory requirements and meet or exceed sponsor expectations. By recruiting, developing and retaining highly qualified & motivated personnel, we achieve and maintain the required level of quality and commitment to sponsors and regulatory agencies.

Our internal quality assurance team, which reports directly to the management, audits all systems and processes at regular intervals as driven by the quality systems & as per ISO/ISMS guideline standards. Our regulatory submissions include the US FDA, WHO, ANVISA, EMA, MHRA, TGA, Health Canada, ISP MoH-Chile, NPCB - Malaysia and many more. Our study data is part of drug dossiers filed with various regulatory authorities in India, EU and US. We have undergone audits/inspections by the DCGI, WHO, USFDA, ANVISA and EMA successfully. Our BA/BE facilities have been inspected by  ISP – MoH Chile, MoH- Turkey and NPCB certified for the conduct of studies for these regulatory submission.

SRC understands that the confidentiality requirements of proprietary information belonging to our clients are of paramount importance. We ensure that the confidentiality of client information, clinical study information as well as information on research participants are maintained through written procedures adopted within the organization.

 

About Semler Research

A privately owned pharmaceutical services company offering best-in-class pharmaceutical, clinical, regulatory & capital solutions across geographies. Our unique delivery model helps clients optimize their resources while saving on time & costs. Our R&D centers are in compliance with GLP, GCP and other regulatory guidelines.