REGULATORY AFFAIRS

Quality and safety are essential to customer trust.

Our Regulatory Affairs unit plays a pivotal role in ensuring that the operating guidelines comply with local laws, Philippine Food and Drug Administration regulations and industry practices. Our Regulatory team enables organizations to navigate the healthcare landscape amidst the growing array of regulatory bodies, constantly-updated guidelines, and emerging product pipelines. Paramount to diverse roles and responsibilities of Regulatory Affairs is to uphold high-quality, safe and effective healthcare products available to consumers.

GBPI Regulatory Affairs Core competencies:

Maintain License to Operate (LTO):
o LTO as Drug, Cosmetics, Household Hazardous Substances, Food, Medical Device Importer and Distributor
o LTO as Drug Re-packer with Certificate of Good Manufacturing Practice (CGMP)
o Phil. Drug Enforcement Agency (PDEA) License to Handle Dangerous Drugs (Importer/Distributor)

Secure Registration of wide range of products, including:
o Pharmaceuticals
o Medical devices
o Food/nutritional products
o Cosmetics and household hazardous products

Process Promotional Permit Applications to FDA

Keen to policy-guided Pharmacovigilance reporting

Conduct internal audit to warehouse activities to ensure compliance to Good Distribution and Good Storage Practices

Coordinate with third party testing centers to facilitate testing of a product (upon request by principal or as mandated by the regulation)

Facilitate trademark registration to Philippine Intellectual Property Office

Other tasks requested by clients, aside from the above mentioned, are evaluated and processed with a high level of professionalism and dedication to excellence.

A multi-disciplinary team of qualified regulatory affairs personnel will work closely with you in all aspects of your clinical trial applications and marketing authorization applications for any products with regulatory requirements. They will further assist you to explore the shortest possible route and optimal timeframe through which you can put your products on the market, and support the Life Cycle Management of your products. Our team provides full regulatory support from the pre-clinical to the post-marketing phases.

At the pre-registration phase, we support your scientific advice requests, prepare and review product dossiers and provide regulatory submission strategy. If you are aiming to market your product in the Philippines, we will closely work with your team, and ensure development of a tailor-made regulatory strategy for your product (portfolio) and we will handle the different procedural hurdles and authority interactions.

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