US FDA approval advantages for pharma companies in another country
Sun. 9 May 2021
In this article, we will try to elaborate a few tips for new pharmaceutical companies, small pharma companies, pharma companies, and biopharmaceutical companies in other countries to understand the US FDA approval advantages and importance for their new drugs and expanding their pharmaceutical business in the pharmaceutical sector (pharma sector).
What is the FDA?
These letters are an abbreviation of Food and Drug Administration. This organization is under the auspices of the United States, Department of Health and is responsible for reviewing the status of all products in the following four areas:
- Food and beverage
- cosmetic products
- Medical Equipment
- Medicines (pharmaceutical drugs, bio pharmaceuticals)
What are the powers and responsibilities of this organization?
- Any manufacturer wishing to sell or export such products to the United States must obtain a set of related licenses and approvals from the FDA (US FDA approval advantages).
- Any new drug must be approved by this organization in order to be sold.
- Having the FDA approval certificates helps companies in marketing and sales of the product.
What are the benefits of obtaining FDA certification (US FDA approval advantages)?
- Registered in the list of FDA approved companies
- View company profile by other traders (importers and exporters) and investors around the world
- Find an FDA-approved business partner for export, import or joint venture
- Review and analyze product composition in the most prestigious FDA laboratories and compare with strict US standards
- Smoothing the export route to the United States and other countries
- Periodically receive the latest scientific findings in the relevant industry
- Access to FDA scientific resources
- Ability to ask scientific questions and get answers
Services that can be provided
- FDA Registration and Annual Renewal (FDA Registration)
- Appoint a representative in the United States for communication between the two parties
- Certificate presentation
- Review of product combinations and product labels and comparison with US standards (Label & Ingredient Review)
- Registration of products and specifications for export to the United States at the US Customs and Protection Organization (FDA Prior Notice)
How to provide services
- Obtain sufficient information and necessary guidance in any way regarding the most suitable services for each company
- Appointing a management representative to contact the country Coordination Office
- Official announcement of the requested services by the applicant
- Transfer of the application to the FDA by the country office
- Transfer of relevant forms to be completed by the applicant company
- Completing the forms and transferring them to the country office
- Signing a contract between the applicant company and the country Coordination Office
- Deposit fees (the currency of the country)
- Send documents and fees to the FDA
- FDA review of documents
- Perform the requested items and submit the certificate within a specified period
Easy Global Training is based in Bethesda, MD in the United States. It is a leading, up-to-date information network in the fields of Regulatory Affairs, quality compliance, and medical affairs for life sciences (drugs, excipients, medical devices, and combination products), food & food ingredients, dietary supplements, and complementary / alternative medicine.
Our portfolio of products includes webinars (live and on-demand), e-learning self-paced modules, in-class training, white papers, e-books, guidelines, best practices, reports, job aids, and e-newsletters. We also provide social media channels with webcasts and interviews from the industry experts, as well as academic and regulatory body experts on regulatory training and quality compliance hot topics, best practices (GMP, GDP. GCP. GLP. GVP, …), guidelines, and regulations at a global level.
For your convenience, we also provide a variety of forms and templates across these fields. Easy Global Training strives to provide a wide network of high-quality resources that are up-to-date and to communicate new updates as well as new insights and competitive points of view. This is a collaborative platform, designed for professionals across a variety of fields to learn and share valuable information related to the latest laws, policies and regulations, while ensuring continuous improvement in global operations, regulatory training, quality compliance, and safety.
Please feel free to browse our collaborator’s site (Neometrix Consulting Inc.).
Please follow us on YouTube, Facebook, LinkedIn, Twitter, Instagram, Pinterest, and Tumblr, to get updates of what is new.