Regulatory Affairs Department

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Regulatory Affairs Department

For inquiries related to Regulatory Affairs Services, please feel free to contact us and we will surely get back to you as soon as possible

Multi-disciplinary team of qualified regulatory affairs senior experts is at your disposal for all aspects of your marketing authorization applications for human health, herbal and medicinal products as well as the regulatory aspects for manufacturing sites and marketing authorization holder. BPS Regulatory Affairs can help you explore the shortest route and timeframe to put your products on the market, and support the Life Cycle Management of your products.

BPS can closely collaborate with your team, and develop a tailor-made regulatory strategy for your product (portfolio) and guide you through the different procedural hurdles and authority interactions. We support all procedures for the preparation, review and submission of your Marketing Authorization Applications in Middle East and North Africa.

BPDS can prepare the national labelling texts and Artworks as well as can review the product information leaflet text and arrange for the translations (Arabic/Farsi/French/Urdu/English), if needed.

Post-registration, BPDS Regulatory Affairs can support the Life Cycle maintenance of variations, line extensions, renewals, PSUR submissions and responses to Authority requests for your respective products.

Our regulatory affairs team helps in navigating this dynamic landscape to ensure that your products and processes meet all relevant regulatory requirements.

Our regulatory affairs team helps in the preparation of dossier in eCTD format which is implemented in many GCC and levant countries.

BPDS regulatory affairs department insure the implementation of the good regulatory practice.

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