Pharmaceutical Licensing Consulting with RDNmed Advantage
The pharmaceutical industry is a continuously evolving sector, and one of the biggest challenges for firms looking to enter this field is the licensing process for their products. Obtaining pharmaceutical licenses in Turkey involves complex legal requirements and detailed procedures. This is where we come in at RDNmed. With our industry experience, we provide pharmaceutical licensing consulting services to guide companies through this process.
The pharmaceutical licensing
process plays a crucial role in ensuring the safety, efficacy, and quality of products. The Turkish Medicines and Medical Devices Agency (TİTCK) is the primary authority overseeing this process. Before applying for a license to TİTCK, the necessary documents and information must be prepared. At RDNmed, we provide support at every stage of the application process, ensuring a fast and smooth completion of the procedures.
Our services include managing the license application process,
conducting necessary clinical trials, preparing drug safety reports, and providing market access consulting. We are with you at every stage of the licensing process for your products. Whether you are in the development stage of a new drug or seeking to innovate with an already licensed product, RDNmed offers the most suitable consulting services to meet your needs.
Having accurate and up-to-date information in the field of pharmaceutical licensing consulting is critical. Rapid changes in the industry and new regulations can make it difficult for companies to ensure compliance. RDNmed continuously monitors industry developments, providing our clients with the latest information and guiding their processes accordingly.
In addition, with our market access consulting services, we ensure that your products can enter domestic markets smoothly. By developing market entry strategies, we facilitate your products’ reach to your target audience and reduce barriers to trade. In addition to the licensing process, we also work to create strategies that contribute to the growth of your company.
RDNmed is not just a consultant in the pharmaceutical licensing process but also your solution partner. We provide all the expertise and experience you need to achieve success in obtaining a pharmaceutical license, entering the market, and gaining a competitive advantage. By contacting us, you can learn how we can support you in pharmaceutical licensing consulting and strengthen your position in the healthcare sector.TITCK’s duties, authorities and responsibilities are as follows:
a) To determine the rules and standards regarding the licensing,
production, storage, sale, import, export, market launch, distribution, service, collection and use of products within its scope of duty, to permit, license, supervise and, when necessary, impose sanctions on public and private legal entities and real persons who will carry out these activities, to perform or have laboratory analyses performed.
b) To examine the health claims of products to be offered for sale with a health declaration and to permit these declarations,
to supervise sales made with unauthorized or false health declarations, to perform or have performed the stopping, collection, collection and destruction procedures and procedures when necessary, to supervise all kinds of advertisements and promotions of these in terms of permits and health declarations and to stop those that are contrary, to determine the procedures and principles of advertising and promotion of medicines, medical devices and products placed on the market and to supervise their implementation.
c) To make, permit and supervise the regulations regarding clinical research on medicines, medical devices and products within its scope of duty.
ç) To prepare the Turkish Pharmacopoeia.
d) To take the necessary measures to ensure that vitally important drugs,
medical devices and products are constantly available on the market.
e) To determine approved institutions for medical devices, to grant licenses,
permits or permits, to conduct inspections and to impose sanctions when necessary.
f) To establish or have established,
operate or have operated warning systems related to drugs, medical devices and products within its scope of duty.
g) To ensure international mutual recognition and accreditation of the institution’s personnel.
ğ) To conduct market surveillance and inspection of drugs,
medical devices and products within its scope of duty, to collect, destroy or have them collected when necessary, to determine safety notification methods for products on the market, to make the necessary notifications, to conduct or have laboratory analyses conducted.
h) To conduct pharmaco-economic evaluations and studies to determine drug prices.
ı) To determine the solution for disputes that may arise between manufacturers,
sellers and users of drugs, medical devices and products within its scope of duty.
i) To monitor and evaluate activities related to its area of responsibility,
to disseminate good practice examples, to make proposals to the Ministry for policy development and necessary regulations.
j) To establish scientific and technical cooperation with national or international public institutions,
universities and private organizations on issues related to its area of responsibility, to conduct joint studies.
k) To carry out the appointment, transfer,
personnel, wage, retirement and similar procedures of the institution’s personnel.
l) To carry out all kinds of purchasing,
leasing, maintenance and repair, archive, administrative and financial services required by the institution’s services
Remember, with the right consulting, you can succeed in your licensing process and establish a lasting presence in the market. RDNmed is a reliable partner in pharmaceutical licensing consulting!