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With India emerging as a credible destination for conducting global clinical trials, FCRL is positioned for dynamic growth. Our proven scientific excellence together with full-scale clinical research capabilities enable us to undertake and deliver challenging studies for our global as well as local partners.
We have extensive working knowledge of a wide range of drug molecules. All activities are carried out in strict compliance with regulatory and ICH GCP requirements. We have successfully cleared regulatory audits from DCGI (India), USFDA, afssaps (France) and ANVISA (Brazil).
We customarily provide drug development regulatory services (for clinical trials, PK/PD/BA/BE studies, and for preparing regulatory dossiers) to various major pharmaceutical companies & sponsors.
Services offered at FCRL include:
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Providing guidance on Indian regulatory environment & requirements, |
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Compiling dossiers, |
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Making regulatory submissions, |
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Liaisoning on behalf of clients, |
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Query resolutions at the office of Drugs Controller General (India), |
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Receiving registration documents on behalf of client and |
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Submission maintenance activities to regulatory authorities. |
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Our clear understanding of Indian and international regulatory requirements and excellent liaisoning facilitates swift approvals. Our interface substantially speeds up the process of regulatory clearance for your protocols and dossiers. |
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