Simpex Admin

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<p><strong>Simpex pharma Pvt. Ltd.</strong> having a good and skilled 
personnel team responsible for establishment of procedures of various 
regulatory authorities, both domestic and international markets.</p>

<p>Regulatory teams cover a broad range of specific skills and 
occupations. Under the best of circumstances, it is composed of a group 
of people who act as a liaison between the potentially conflicting 
worlds of government, industry, and consumers to help make sure that 
marketed products are safe and effective when used as advertised. We 
Simpex Pharma Pvt. Ltd. regulatory affairs negotiate the interaction 
between the regulators (the government), the regulated (industry), and 
the market (consumers) to get good products to the market and to keep 
them there while preventing bad products from being sold.</p>

<p>The regulatory affairs involvement is in the development of new 
products from early on, by integrating regulatory principles and by 
preparing and submitting the relevant regulatory dossiers to concerned 
health authorities and is actively involved at every stage of 
development of a new product and in the post-marketing activities with 
authorised medicinal products.</p>

<p>Our Regulatory professionals ensure that the information and data to 
be conveyed and discussed with the regulatory bodies are presented in 
the right form. They develop the regulatory strategy, arrange agency 
meetings, prepare and compile questions and briefing documents, attend 
the meetings and manage all communication with the health agencies.</p>

<p>At later stages of product development, it is responsible for the 
submission of the registration dossier, e.g. Marketing Authorization 
Applications (MAA) in the respective countries. Our team specialises in 
managing the communication and negotiations with the authorities and is 
accountable for maintenance of marketing authorizations and the 
life-cycle management of a product.</p>

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