Regulatory Services

Regulatory Services
Product Description

Azidus provides regulatory services such as: Preparation of regulatory dossiers for semi-regulated and regulated markets, preparation of dossiers in CTD format for market authorization in various countries, consultation, review and preparation of all modules of common technical document for regulatory submission liaison with drug regulatory agencies during submission, answering queries and preparation of tabulated responses/applicant's response documents for RMS and CMS comments in centralized (CP), decentralized (DCP), mutual recognition (MRP) and national submission (NP) procedures, preparation of the regulatory dossier as per the requirements of the regulatory agencies, preparation of clinical overviews, non-clinical overviews, clinical study reports, non-clinical study reports, summary of product characteristics and patient information leaflet, following up with the regulatory agencies in case of decentralized/centralized/mutual/national procedures and carrying out query clarification and query resolution in consultation with the sponsors.

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AZIDUS LABORATORIES LIMITED

  • IN
  • 2015
    On CPHI since
View company profile

AZIDUS LABORATORIES LIMITED

  • IN
  • 2015
    On CPHI since
View company profile

More Products from AZIDUS LABORATORIES LIMITED (6)

  • Bioavailability and Bioequivalence studies

    Product Bioavailability and Bioequivalence studies

    Azidus has a dedicated volunteer mobilization team which does motivation and mobilization of the volunteers. More than 4000 volunteers including adult healthy males & females, post menopausal females and geriatric volunteers are registered in the data bank. Biometric software is used for volunteer identifi...
  • Bioanalytical Services

    Product Bioanalytical Services

    Azidus provides bioanalytical services such as: Development of protocols for Bioanalytical method development, method validation, develop and validation of bioanalytical methods far in advance, method development & validation in various mediums like plasma (human, animals), whole blood, urine and feaces, p...
  • Phase I - IV Services

    Product Phase I - IV Services

    Azidus has experienced team of professionals to handle the all phases of drug development from phase I to phase IV clinical trials. The technical team can design and execute the phase trials at committed time as per the current International regulatory guidelines. Trials: Study feasibility assessment, inve...
  • Medical Writing

    Product Medical Writing

    Azidus provides medical writing services such as: Development of protocol, informed consent form (ICF) and case report form (CRF) development, preparation of clinical report, analytical report and statistical report, adverse event and concomitant medication reporting using m=MedDRA and WHO-DD dictionaries,...
  • Clinical Data Management

    Product Clinical Data Management

    Azidus provides clinical data management services such as: Designing of CRF using appropriate software, data management plan, data capture and database designing, independent double data entry verification and cross checking, complete data validation and generation of data validation report, quality assura...
  • Pharmacovigilance Services

    Product Pharmacovigilance Services

    Azidus provides pharmacovigilance services such as: Assessment of serious adverse event (SAE) and reporting during clinical trials, submission of reporting forms 3500A, Blue card, Yellow card, CIOMS I to respective drug regulatory agencies within timelines, adverse drug reaction (ADR) assessment and report...

AZIDUS LABORATORIES LIMITED resources (1)

  • BA/BE Capabilities

    Brochure BA/BE Capabilities

    AZIDUS is a full service clinical research organization catering to the technical needs of pharmaceutical and biotechnology industries for the conduct of BA/BE studies, Clinical trials, Clinical Data Management, Pharmacovigilance and Regulatory submission to the Global drug regulatory agencies.