New Product Authorization
If we are talking about New Product Authorization, that means the company’s product is a final product. It is already in its shape and form to come into the market by passing all the tests and permissions from the government where the product manufacturers are planning to commercialize its final product. Initially some submission application, like Clinical Trial Application (CTA), Biological License Application (BLA), Abbreviated New Drug Application (ANDA), New Drug Application (NDA), Investigational New Drug (IND), and other regional applications, needs to be filed by which the organization can obtain its market authorization from the target country’s Health Authority. This is worked on for the commercialization of a final product in a specific or targeted region.
Authorization processes follow either decentralized procedure within the European Union or a mutual recognition or a central approval or purely national procedure as it occurs in most of the countries worldwide with rules and requirements as per national legislation in force. A new authorization process is bought into existence for the Identification of Medical Products (IDMP) in the European Union. Initially, the drugs are submitted to Health Authorities with supporting documents with geo-specific requirements. Submission for applications are frequently updated by Health Authorities worldwide, this is why this requirement is known to be dynamic in nature. To track them continuously is the most challenging task for any regulatory life science company to keep up with error-free submissions and quick market authorizations.
For all types of products, formulations and regulatory life science tasks, like Active Pharmaceutical Ingredient (API), Consumer Healthcare Products, New Chemical Entity (NCE), Tammina Life Science plays a vital role for new market authorizations and initial submissions to global clients. Tammina Life Science has very efficient regulatory life science team who has expertise and experience in handling region based, geo-specific market authorizations like World Health Organization (WHO), Therapeutic Products Database (TPD), Commonwealth of Independent States (CIS), Medicines Control Council (MCC), Association of Southern Asian Nations (ASEAN), Asia Pacific (APAC), Pharmaceuticals and Medical Devices Agency (PMDA), Ministry of Health (MoH), Therapeutic Goods Administration (TGA), Gulf Cooperation Council (GCC), European Directorate for the Quality of Medicines (EDQM), Middle East and North Africa (MENA), Latin America (LATAM), United States Food and Drug Administration(USFDA), European Medicines Agency(EMA) and many more regions.
Why Tammina Life Science Regulatory Life Science –
- Our team has experts and great experience in compilation and submission.
- Our team has detailed knowledge and stays updated to all geo-specific Health Authorities.
- Our regulatory life science professionals are experts to handle pre-submission administrative activities.
- As per current guidelines and requirements, our experts publish the ANDA application Electronic Common Technical Document (eCTD).
- Our team has experts and great experience in compilation and submission and provides end-to-end regulatory support for development, registration and approvals of drugs and other products.
- Our company works on all regulatory affairs from Dossier strategy to Regulatory content authoring to final submissions.
- For both Pharmaceutical and Biological products we provide Biological License Application, Abbreviated New Drug Application, Investigational Medicinal Product Dossier, New Drug Submission, Abbreviated New Drug Submissions, Investigational New Drug, Clinical Trial Application, New Drug Application.
- We request for Pre-assigned ANDA number and do the gap analysis of submission batch documents.
- We give designing for everything till the final product like raw materials, starting materials, excipients, in-process intermediates, packing materials and even drug substance.
Marketing Authorization Applications for many regions like Australia, South Africa, Gulf Countries, Asia Pacific, Middle East, Latin America.