Regulatory and Medical Affairs experts are essential to the success of any biopharmaceutical or medical device company. They provide regulatory guidance and support on the requirements by Regulatory Authorities or Agencies, perform safety analysis and adverse drug reactions monitoring, prepare clinical trial applications, provide overall medical strategy and day-to-day operations include advisory, medico-marketing and medical governance. We offer regulatory and medical affairs services to develop and implement strategies compliant with regulatory or requirements for biopharmaceutical . Some of our services include the following:
When it comes to regulatory and medical affairs work in the biopharmaceutical and medical device industry, you need a partner that understands your goals. We are committed to providing reliable regulatory and medical affairs services that help our clients bring their products to market. We offer an array of consulting services to support your needs. If you’re ready for exceptional service when it comes to regulatory and medical affairs, contact us today!
We are licensed by the Medical Device Authority (“MDA”) as authorized representative (“AR”), distributor, and importer. MDA is a statutory body under the Ministry of Health Malaysia which regulates medical devices under the Medical Device Act 2012 (Act 737). Under the regulation, manufacturers outside of Malaysia are required to appoint an AR to submit the registration of their medical devices.