Biotech Pharma Services is a pharmaceutical company focusing on growth through the acquisition and in-licensing of Hematology, Oncology, Autoimmune, Urology, Neurosurgery, Nephrology.
Biotech Pharma invest in Human resources and Technology to execute the best supply and delivery plans and we do provide:
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.
BPS 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, BPS Regulatory Affairs can support the Life Cycle maintenance of variations, line extensions, renewals, PSUR submissions and responses to Authority requests for your respective products.
BPS regulatory affairs department insure the implementation of the good regulatory practice.
Biotech Pharma with its partner Glomac Medical GmbH based in Germany built concept for the regional representation providing the best services in fast and sustainable market access into the MENA and some of the Asian markets.
With our strategic trusted partners, our enormous experience, our market & local culture knowledge; we will improve the patient quality of life.
Biotech Pharma & Glomac Medical will provide the best market analysis in order to evaluate the potential of the company products with the following service details: