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Baupharma is a service provider for pharmaceutical companies focused on Regulatory Affairs, Pharmacovigilance and Business Development. Our regions of expertise are EU, MENA and LATAM. Our aim is to build Pharma, ensure that new products reach the market meeting legislation and agencies' requirements on pre and post marketing basis. But, specially, our deepest focus is to work close to you and give all support needed. Since we have been working many years on the sector and we understand the importance of knowing you have a partner on whom you can always rely.

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Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate), Baupharma, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development, EU, CIS, MENA, Registration, Renewal, variation, license, local QPPV, EU QPPV, Safety Officer, in licenses, out license, risk management plan, PSUR, Price and reimbursement, cpp, certificate pharmaceutical product, distributor, local company representatives, sales forces, environmental risk assessment, psmf, nonclinical overview, clinical overview, DSUR, SOP, CAPA, CA/PA, PIL, PL, SMPC, Labelling, literature articles, phv, marketing, marketed, MAH, PSMF, literature research, local literature research, global literature research, safety, ICSR, XEVMPD, IDMP, CP, DCP, NP, centralize procedure, decentralize procedure, national procedure, GCC, submission, regulatory support, gap analysis, ectd, e-ctd, publishing, module 1, module 2, module 3, module 4, module 5preparation, cover letter, application form, electronic application form, artwork, braille, mockup, mock up, mock-up, consultation with target patient groups, readability testing, nonclinical summary, clinical summary, NEES, ctd, pharmaceuticals, pharma, we build pharma, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development, EMA, ages, fagg-afmps, bda, almp, moh, suki, laegemiddelstyrelsen, ravimiamet, fimea, ansm, sante, bfarm, pei, eof, ogyei, imca, hpra aifa, zva, vvkt, ms, etat, medicinesautority, graadt, van, roggenweg, urpl, gif, infarmed, anm, sukl, jazmp, aemps, lakemedelsverket, mhra, astrian agency health food safety, federal agency medicines health products, Bulgarian drug agency, agency medicinal products medical devices Croatia, ministry health, pharmaceutical services, state institute drug control, Danish medicines agency, atate agency medicines, national agency safety medicine health products, federal institute drugs medical devices, paul ehrlich institute, national organization medicines, national institute pharmacy nutrition, Icelandic medicines agency, health products regulatory authority, Italian medicines agency, state agency medicines, office of health, department pharmaceuticals, state medicines control agency, ministry health, medicines authority, medicines evaluation board, healthcare inspectorate, Norwegian medicines agency, office registration, medicinal products, medical devieces biocidal products, chief pharmaceutical inspectorate, national authority medicines health products, national medicines agency, state institute drug control, agency medicinal produtcts medical devices republis Slovenia, Spanish agency medicines health productsm medical products agency, medicines healthcare produtcs regulatory agency, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Oiland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom, UK, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Linya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syriam Tunisia, United Arab Emirates, UAE, Yemen, Afghanistan, Armenia, Azerbaijan, Chad, Cyprus, Djibouti, Eritrea, Georgia, Mali, Mauritania, Niger, Pakistan, Sahrawi Arab Democratic Republic, Somalia, South Sudan, Turkey, SFDA, Japan, pmda, jpma, ands, eda, nhra, dchq, Iran medicine agency, moh, jfda, medinfo hsc, moph, pharm, azstand, gdna, ndea, dra, tick, Turkish medicines medical devices agency, TMMDA. Gynecology, Urology, Nephrology, Obstetrics, Dermatology, Infection, Infectious, Diseases. 16 Feb

Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate)

Pharmacovigilance. Update Adverse Reactions in Japan (Hydroxyzine hydrochloride, Hydroxyzine pamoate) In order to maintain the safety of the patients, Agencies around the world are continuously updating their requirements. As a result of the adverse effects that a drug may have in the user. In this case, Japan published a new requirement in the clinically significant adverse […]

Baupharma, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development, EU, CIS, MENA, Registration, Renewal, variation, license, local QPPV, EU QPPV, Safety Officer, in licenses, out license, risk management plan, PSUR, Price and reimbursement, cpp, certificate pharmaceutical product, distributor, local company representatives, sales forces, environmental risk assessment, psmf, nonclinical overview, clinical overview, DSUR, SOP, CAPA, CA/PA, PIL, PL, SMPC, Labelling, literature articles, phv, marketing, marketed, MAH, PSMF, literature research, local literature research, global literature research, safety, ICSR, XEVMPD, IDMP, CP, DCP, NP, centralize procedure, decentralize procedure, national procedure, GCC, submission, regulatory support, gap analysis, ectd, e-ctd, publishing, module 1, module 2, module 3, module 4, module 5preparation, cover letter, application form, electronic application form, artwork, braille, mockup, mock up, mock-up, consultation with target patient groups, readability testing, nonclinical summary, clinical summary, NEES, ctd, pharmaceuticals, pharma, we build pharma, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development, EMA, ages, fagg-afmps, bda, almp, moh, suki, laegemiddelstyrelsen, ravimiamet, fimea, ansm, sante, bfarm, pei, eof, ogyei, imca, hpra aifa, zva, vvkt, ms, etat, medicinesautority, graadt, van, roggenweg, urpl, gif, infarmed, anm, sukl, jazmp, aemps, lakemedelsverket, mhra, astrian agency health food safety, federal agency medicines health products, Bulgarian drug agency, agency medicinal products medical devices Croatia, ministry health, pharmaceutical services, state institute drug control, Danish medicines agency, atate agency medicines, national agency safety medicine health products, federal institute drugs medical devices, paul ehrlich institute, national organization medicines, national institute pharmacy nutrition, Icelandic medicines agency, health products regulatory authority, Italian medicines agency, state agency medicines, office of health, department pharmaceuticals, state medicines control agency, ministry health, medicines authority, medicines evaluation board, healthcare inspectorate, Norwegian medicines agency, office registration, medicinal products, medical devieces biocidal products, chief pharmaceutical inspectorate, national authority medicines health products, national medicines agency, state institute drug control, agency medicinal produtcts medical devices republis Slovenia, Spanish agency medicines health productsm medical products agency, medicines healthcare produtcs regulatory agency, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Oiland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom, UK, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Linya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syriam Tunisia, United Arab Emirates, UAE, Yemen, Afghanistan, Armenia, Azerbaijan, Chad, Cyprus, Djibouti, Eritrea, Georgia, Mali, Mauritania, Niger, Pakistan, Sahrawi Arab Democratic Republic, Somalia, South Sudan, Turkey, SFDA, Japan, pmda, jpma, ands, eda, nhra, dchq, Iran medicine agency, moh, jfda, medinfo hsc, moph, pharm, azstand, gdna, ndea, dra, tick, Turkish medicines medical devices agency, TMMDA. Gynecology, Urology, Nephrology, Obstetrics, Dermatology, Infection, Infectious, Diseases. 15 Feb

New EPARs by EMA. Help your registration!

New EPARs by EMA. Help your registration! Another week and EMA has released new EPARs for several products. Since you may be thinking about registering a product with their active substance, you may want to take a look. Filgrastim Hexal: a solution for injection or infusion (drip into a vein) in a prefilled syringe. It contains the […]

Baupharma, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development, EU, CIS, MENA, Registration, Renewal, variation, license, local QPPV, EU QPPV, Safety Officer, in licenses, out license, risk management plan, PSUR, Price and reimbursement, cpp, certificate pharmaceutical product, distributor, local company representatives, sales forces, environmental risk assessment, psmf, nonclinical overview, clinical overview, DSUR, SOP, CAPA, CA/PA, PIL, PL, SMPC, Labelling, literature articles, phv, marketing, marketed, MAH, PSMF, literature research, local literature research, global literature research, safety, ICSR, XEVMPD, IDMP, CP, DCP, NP, centralize procedure, decentralize procedure, national procedure, GCC, submission, regulatory support, gap analysis, ectd, e-ctd, publishing, module 1, module 2, module 3, module 4, module 5preparation, cover letter, application form, electronic application form, artwork, braille, mockup, mock up, mock-up, consultation with target patient groups, readability testing, nonclinical summary, clinical summary, NEES, ctd, pharmaceuticals, pharma, we build pharma, Regulatory Affairs, Pharmacovigilance, Medical Translations, Medical Writing, Business Development, EMA, ages, fagg-afmps, bda, almp, moh, suki, laegemiddelstyrelsen, ravimiamet, fimea, ansm, sante, bfarm, pei, eof, ogyei, imca, hpra aifa, zva, vvkt, ms, etat, medicinesautority, graadt, van, roggenweg, urpl, gif, infarmed, anm, sukl, jazmp, aemps, lakemedelsverket, mhra, astrian agency health food safety, federal agency medicines health products, Bulgarian drug agency, agency medicinal products medical devices Croatia, ministry health, pharmaceutical services, state institute drug control, Danish medicines agency, atate agency medicines, national agency safety medicine health products, federal institute drugs medical devices, paul ehrlich institute, national organization medicines, national institute pharmacy nutrition, Icelandic medicines agency, health products regulatory authority, Italian medicines agency, state agency medicines, office of health, department pharmaceuticals, state medicines control agency, ministry health, medicines authority, medicines evaluation board, healthcare inspectorate, Norwegian medicines agency, office registration, medicinal products, medical devieces biocidal products, chief pharmaceutical inspectorate, national authority medicines health products, national medicines agency, state institute drug control, agency medicinal produtcts medical devices republis Slovenia, Spanish agency medicines health productsm medical products agency, medicines healthcare produtcs regulatory agency, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Oiland, Portugal, Romania, Slovakia, Slovenia, Sweden, United Kingdom, UK, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Linya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syriam Tunisia, United Arab Emirates, UAE, Yemen, Afghanistan, Armenia, Azerbaijan, Chad, Cyprus, Djibouti, Eritrea, Georgia, Mali, Mauritania, Niger, Pakistan, Sahrawi Arab Democratic Republic, Somalia, South Sudan, Turkey, SFDA, Japan, pmda, jpma, ands, eda, nhra, dchq, Iran medicine agency, moh, jfda, medinfo hsc, moph, pharm, azstand, gdna, ndea, dra, tick, Turkish medicines medical devices agency, TMMDA. Gynecology, Urology, Nephrology, Obstetrics, Dermatology, Infection, Infectious, Diseases. 14 Feb

Update multi-language labelling in EU

Update multi-language labelling EU Looks like January was a productive month for CMDh. On their last meeting they have agreed to publish a set of links with special guidance on update multi-language labelling EU developed by some Member States. The update of multi-language labelling in EU will be available under “Product Information” on their website section. As an illustration, […]

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