Artemisia Consultancy & Engineering
Services Provided
• To save time while helping you meet target deadlines,
• Share our experience on new markets and products
• Help your business grow with our global licensing experience and knowledge
• Our goal is to help you achieve your business goals.
With partners and teammates who support regulatory, pharmacovigilance, GMP audits, marketing issues, in Turkey, USA, Canada, Europe, UK, CIS countries (Russia, Azerbaijan, Georgia, etc.), Balkan countries, Latin America, West and South Africa, Asia-Pacific region, GCC , we provide services in the fields of business development.
Together with local partners and local teammates, we support pharmaceutical companies in many parts of the world with regulatory and business development projects.
The details are as follows:
• Provide local support and advice in the dossier preparation processes for registration applications in different parts of the world in CIS countries, Balkan countries, European Union, UK, Latin American countries, United States, Canada, Asia-Pacific, Gulf countries, African countries, MENA countries and Turkey, taking into account the country's regulations.
• Support the preparation of type change files, license transfer files according to national regulations
• In licensing projects in different countries; support and advice on project management and licensing strategy
• Support “Pricing” taking into account country regulations.
• Provide advice and training on regulations in different regions
• Plan projects in companies located in different parts of the world, discuss details, find solutions through video conference and teleconferences
• Provide support on pharmacovigilance in Turkey, USA, Canada, Europe, UK, CIS countries (Russia, Azerbaijan, Georgia, etc.), Balkan countries, Latin America, West and South Africa, Asia-Pacific region, GCC
• Follow-up of the project authorization procedure in the country concerned with local representatives with solid and good communication, giving relevant reports
• Meeting with health authorities and the Ministry through local contacts and representatives in markets such as CIS countries (Russia, Azerbaijan, Georgia, etc.), Balkan countries, European Union, Latin American countries, United States, Canada, Asia-Pacific, Africa, Gulf countries and MENA countries.
• Preparation of response reports by finding solutions to questions and deficiencies related to requests by health authorities / ministerial authorities
• Follow-up of projects related to business development and presentation of reports on the subject
• Conduct and guide a "GAP analysis" regarding the market or the compliance of the product with the registration procedure in the country
• Provide support in necessary areas by finding contact persons and communication network in different locations related to licensing, pharmacovigilance, business development
• Find different and rare products that companies are looking for and introduce GAP analysis, P&L analysis, give trend information and support them through contact persons.
• Support on Local Marketing Authorization Holding is given