Regulatory Affairs Department at OBS ensures compliance with all of the regulations and laws governing Drug Registration in Pakistan and in other countries. Our dedicated team is responsible for the presentation of registration documents to regulatory agencies, and carries out all the subsequent negotiations necessary to obtain and maintain marketing authorization for the diversified range of products.
- One of our core responsibilities of regulatory affairs is to ensure the safety compliance of standards as per the regulation of territory/country across the Organization.
- Ensure timely submission of Renewals and New Product Dossiers.
- Develop regulatory strategy for the product’s life cycle including consideration of local and international regulatory requirements, meeting international filings and revision of plans as guidelines change.
- Facilitate interaction with regulatory agencies, such as in meetings and conference calls, negotiations during development stages, submissions and submission approval process.
- Respond to technical queries/additional information.
- We work in liaison with Business Development/ R& D, Production and QA /QC.
- Monitor development of Artwork to ensure all Regulatory requirements are met for both for local and international markets.
- To ensure regulatory compliance of all promotional materials and labeling compliance of every single product supplied in the market.