Numerous Lifesciences,Biotechnology and Pharma majors have already expanded their domain in regulatory affairs.The expansion is in full swing and majorly providing services in regulatory affairs domain to Pharma and BioPharma clients followed by creating and implementing development plans to meet all the regulatory requirements concerning approval of new drugs,it’s safety and providing support for marketed products and lifecycle management.
The regulatory affairs cell is responsible for providing Significant support to the products from pre development stage to post marketing stage in therapeutic areas such as CNS, oncology, dermatology, inflammation, endocrinology and cardiovascular disorders. Moreover the companies are giving break to the professionals with world class experience and expertise in navigating through the drug development process with the national and international drug regulatory authorities. Thus making professionals capable to perform and excel with specialized regulatory knowledge in areas like health outcomes and post-approval research to provide clients unique regulatory insight in both the pre- and post-approval environment.
These companies are offering numerous services to their life sciences clients. The regulatory affairs professionals involved will conduct global strategic planning, manage submission and liaison activities with health authorities and handle medical writing of regulatory documents.
Many of the MNCs are trying hard to curtail time and making the procedures smoother and easier by employing Regulatory Prep Services where the procedures for chemistry, manufacturing and controls documents (CMC) converted in the Common Technical Documents (CTD) format. New services helps provide briefing of procedures throughout formulation and process development in the common format established by the International Commission on Harmonization for submitting NDAs to the FDA and regulatory agencies in the respective countries
The regulatory affairs cell is responsible for providing Significant support to the products from pre development stage to post marketing stage in therapeutic areas such as CNS, oncology, dermatology, inflammation, endocrinology and cardiovascular disorders. Moreover the companies are giving break to the professionals with world class experience and expertise in navigating through the drug development process with the national and international drug regulatory authorities. Thus making professionals capable to perform and excel with specialized regulatory knowledge in areas like health outcomes and post-approval research to provide clients unique regulatory insight in both the pre- and post-approval environment.
These companies are offering numerous services to their life sciences clients. The regulatory affairs professionals involved will conduct global strategic planning, manage submission and liaison activities with health authorities and handle medical writing of regulatory documents.
Many of the MNCs are trying hard to curtail time and making the procedures smoother and easier by employing Regulatory Prep Services where the procedures for chemistry, manufacturing and controls documents (CMC) converted in the Common Technical Documents (CTD) format. New services helps provide briefing of procedures throughout formulation and process development in the common format established by the International Commission on Harmonization for submitting NDAs to the FDA and regulatory agencies in the respective countries
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