ClinSync
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      • Brief Overview
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      • Brief Overview
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ClinSync

ClinSync understand the critical importance of QA & Regulatory aspects for a drug development program. We have dedicated teams for QA & Regulatory. The team is responsible to liaison with regulatory agency to navigate the complete and accurate regulatory approval process viagra pas cher for conduct of a clinical trial and BA/BE Studies. The QA & Regulatory Affairs Team consists of individuals having an in-depth knowledge of different regulatory guidelines such as DCGI, FDA, EMEA. The team is updated with all changes and modifications taking place in current regulatory guidance and most recent versions of guidance. We can help you deal with emerging regulatory issues that arise during the product development program.

Services

Independent monitoring of the Studies by our QA team

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.

End to End Services Includes

Oncology

HIV/ TB/ Malaria/ Hepatitis and other infectious conditions

Post menopausal women

Dermatology- Transdermal patches, Gel/ Foam/ Cream, Cumulative Irritation studies & Skin sensitization studies

Hepatic Impairment

Renal Impairment (at partner Kidney Center)

Hypogonadal studies

Contraceptive studies

Cardiovascular and Metabolic Diseases- Cardiac Failure & Diabetes

  • Bioanalytical Services
  • Biostatistics
  • DMPK Services
  • Early Stage Clinical Development
    • Brief Overview
    • Cardiac Safety/ TQT studies
    • Facilities in General
    • Phase I
  • Late Stage Clinical Development
    • Brief Overview
    • Data Management
    • Program, Project & Study Management
    • Site Management & Monitoring
    • Temporary Staffing/Flexible Sourcing Solutions
  • Medical Writing
  • Oncology and Special Population services
  • Pharmaco Vigilance Services
  • Quality Assurance & Regulatory Services
  • Toxicology
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