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follows:

• Ensuring the compliance

• Ensuring the ease of business

• Ensuring effective communication

• Ensuring effective coordination

• Applying and monitoring drug approval application

• Updating the changes

• Assisting product launching

• Reviewing of documents

• Liaisoning between authorities and companies

DRUG DEVELOPMENT TEAMS

Drug Development Process

Drug development is a process of bringing a new pharmaceutical drug to the market

after a lead compound has been identified by the process of drug discovery. Regulatory

professionals are involved in each stage of the drug development process. The stages

involved in the drug development process are as follows:

• Drug discovery and target validation

• Pre-clinical testing

• Investigational new drug application filing

• clinical studies (phase 1, phase 2, phase 3)

• New drug approval application filing

• FDA review and decision

• Phase 4 clinical studies

Because of the different phases involved in the drug development process, a team is

required as no single person is expertise in all fields. This team is a combination of

scientific as well as other discipline professionals. It mainly involves a diverse group

of professionals with different approaches to the development process. The team mainly

composed of:

• Discovery and development group

• Non-clinical group

• Clinical group

• Regulatory group

• Marketing group

• Engineering group

• Legal group

• Others

The success of any drug development team depends upon time management and

resource management which can be done by the following ways:

• Plan and re-plan carefully

• Execute the plan appropriately

• Hire the people who want to get the project done

• Differentiate what is necessary and what is not

• Have patience