Regulatory Strategies / Expert Views
Regulations pertaining to pharmaceutical products are continuously changing...
Read More ➔The Food and Drug Administration (FDA) of Philippines regulates and oversees the safety, efficacy, and quality of pharmaceutical products that include medical devices, cosmetics, and food in addition to medicines. The medical device and pharmaceutical markets in the Philippines rely on foreign manufacturers which creates ample opportunities for foreign organizations that wish to enter the market. To distribute medicinal products in Philippines, pharmacovigilance consulting firm must obtain a product registration certificate and a License to Operate from the FDA. However, the requirements for the certificate application are different depending on whether the product is a new drug or a generic. Navigating through these requirements can be challenging for foreign manufacturers that are unfamiliar with the market. Therefore, for successful product registration and market authorization, manufacturers are encouraged to partner with those that have successful experience in the market.
As a leading global contender, DDReg’s regulatory services in Philippines provides ongoing support and development of customized strategies during all regulatory phases while keeping track of the most recent regulatory requirements to ensure high quality and timely submissions. We deliver reliable safety measures, ensure risk mitigation, and collaborate with experts to facilitate effortless delivery of product launches, regulatory filings, and market authorizations.
Regulations pertaining to pharmaceutical products are continuously changing...
Read More ➔Pharmaceuticals and other medicinal products need to be prior authorized by...
Read More ➔A gap analysis is a regulatory review process that identifies data gaps in the technical...
Read More ➔Regulatory issues arise unexpectedly and can create significant strain on a company’s...
Read More ➔DDReg provides expert consulting and efficient services for quality Drug Substance...
Read More ➔When it comes to regulatory strategies, CMC documentation play a crucial role in developing...
Read More ➔Managing the post-approval life cycle of a product is an essential component to sustaining...
Read More ➔Administrative documents are an integral component of regulatory submissions and constitute key certifications...
Read More ➔The regulatory approval pathway for Abbreviated New Drug Applications (ANDAs) is relatively complex....
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