Durst (Delsalt)It is a global pharmaceutical consulting company that maintains exchanges and contacts with multiple industry associations in Europe and the United States. We have a wealth of global drug information resources, including solid oral preparations, injections, eye drops, topical preparations and other dosage forms. product. Durst has rich experience in the registration of products in developed countries such as the European Union and the United States, and has helped many pharmaceutical companies to complete the registration of products in the European Union and the United States. According to the needs of pharmaceutical companies, to help pharmaceutical companies through different ways to enter the developed European and American markets.

1. Product Registration

Durst has extensive experience in the international registration of products. Durst project experts should help many Chinese and multinational companies such as Shenzhen Haibin Pharmaceutical, Huiling Pharmaceutical and Anshi Pharmaceutical to complete the EU and US registration of products. Durst can provide a number of services in product registration, including but not limited to the following:

(I) Regulatory Compliance Review

According to the customer's product characteristics and the requirements of the target country, formulate detailed regulatory reporting strategies, and guide customers to establish the corresponding regulatory system to ensure that the products fully meet the regulatory requirements.

Review and Analysis of (II) Technical Documents

According to the characteristics of the product, review the CTD file of the product, check the existing regulatory differences, help the enterprise to establish the relative reporting strategy and guide the enterprise to carry out the corresponding experiment.

(III) registration document writing

According to the customer's needs, Durst will provide documentation including the preparation of each module of the product, including pharmacovigilance and other content. When Durst helps enterprises to compile documents, he will sign corresponding confidentiality agreements with customers to ensure that customers' products can be well protected.

(IV) Pharmacovigilance Services

According to the requirements of international pharmaceutical regulations, drug regulatory authorities and enterprises need to have corresponding pharmacovigilance activities for drugs during the registration process and after the products are put on the market. Durst will provide corresponding pharmacovigilance services according to the needs of enterprises or customers.

(V) MAH Agent

According to the requirements of the European Union and the United States, pharmaceutical companies should have corresponding product agents in the local area. Durst has rich experience in product agency in Europe and the United States, will help enterprises to carry out MAH agency services. At present, it has helped many domestic enterprises to carry out product agency.

(VI) GMP Advisory Services

Durst helps global enterprises to carry out GMP consulting services. At present, its services span the European Union, North America, South America and China. Durst has helped many enterprises to carry out integrated GMP solutions in China. On-site guidance to enterprises to improve the GMP system, verify the implementation and personnel training, to help a number of enterprises to complete the EU and FDA certification.

(VII) GMP Audit

Durst will help pharmaceutical companies to conduct GMP simulation audits and help domestic and multinational companies such as Lizhu Monoclonal, Shanxi Nuocheng Pharmaceuticals, Guangzhou Baiyunshan, Anshi Pharmaceuticals and other GMP audit services.

Submission of (VIII) information

Durst will help enterprises complete the data submission during the registration period. At the same time, according to customer needs, it can provide services such as data submission after subsequent registration, including fee submission, to help enterprises provide one-stop service.
(IX) other services

Durst also provides other ancillary services, such as helping companies contact product clinical trial institutions in the European Union and the United States, assisting in project signing, following up on clinical trial results, and regularly feeding back clinical data to customers.

Introduction of 2. products

(I) contract processing outsourcing (Contract Manufacture Organization,CMO): by the European drug marketing license holding company, entrusted to Chinese pharmaceutical enterprises production, entrusted to assist Chinese pharmaceutical enterprises to obtain EU GMP certification, production of drugs sold to the entrusted company, by the entrusted company sold to EU member states.

(II) EU drug marketing license (Marketing Authorization,MA) transfer: EU drug marketing license holders can be transferred to other pharmaceutical companies in the EU, Durst has multiple products that can be transferred at a low price, and companies can contact Durst directly.

(III) generic drug (Abbreviative New Drug Application,ANDA) transfer: Abbreviative New Drug Application (abbreviated new drug application), referred to as ANDA. According to the U.S. Food, Drug and Cosmetic Act (FDCA) and the U.S. Federal Regulatory Act 21 CFR Part 21, generic drugs after the patent period are applied for marketing according to this procedure. The US ANDA registration is equivalent to China's generic drug registration, which is simpler than new drug registration.

(IV) new drug technology transfer: the transfer of new drug patents developed by European and American research and development institutions, in the clinical stage or on the market.

Details can be contacted free of charge: 188 2600 7039 for project consultation.