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.
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.
HIV/ TB/ Malaria/ Hepatitis and other infectious conditions
Post menopausal women
Dermatology- Transdermal patches, Gel/ Foam/ Cream, Cumulative Irritation studies & Skin sensitization studies
Renal Impairment (at partner Kidney Center)
Cardiovascular and Metabolic Diseases- Cardiac Failure & Diabetes