Regulatory Authorities in both developed and developing countries share the responsibility of ensuring the access of safe and effective medicines to patients. For better treatment safety and efficacy for the drugs must be justified and rationalize for public security. The quality, safety, efficacy data has its own importance in the registration dossier. The International Conference on Harmonization (ICH) Common Technical Document (CTD) can serve as a resource for most local Marketing Authorization (MA) applications. Additionally a significant amount of mandatory and highly country specific documentation require strategic planning and allocation for successful and timely local approvals. Regulatory involvement in the drug approval process which directly/indirectly accelerated the launching of drug into market. The regulatory documents whether in-house of documents to be submitted to regulatory authorities should be carefully reviewed by the skilled personal to minimize raised by the regulatory agencies and speed up the approval process.