Regulatory Services

Regulatory Services

• 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.