Registration and Submission

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Registration and Submission

The so-called drug registration and submission represents that the state food and drug administration (FDA), in accordance with the application of the drug registration applicant, makes a systematic evaluation of the safety, effectiveness and quality controllability of the drugs to be sold along with the legal procedure, and then decides whether to agree with the procedure for approval of the application. The complex and time-consuming registration process of pharmaceuticals and biologics is becoming more and more challenging for companies that are developing new technologies to comply with increasingly stringent regulations and health services. Despite the extremely complex technology, BOC Sciences has the expertise and long-term experience in preparing and submitting drug and biologicals registration documents to the health sector in various areas of treatment. Generally, there are five types of drug registration and submission:

Application of investigational new drug (IND)

Because the new drugs have not yet been used for clinical research, relevant clinical research may need to be carried out in different places, and the current federal law in the United States requires drug sales permission before the trans state transport or distribution; therefore, the drug applicant needs to seek legal immunity, and the IND application is from the FDA access to the technical path of such legal immunity.

When the drug applicant has obtained sufficient data to show that it has been able to meet the FDA sales approval requirements in terms of safety and effectiveness, the applicant needs to submit NDA to FDA for the sale approval application. The application data must cover drug research data obtained with specific techniques, including chemistry, pharmacology, medicine, biopharmaceutics and statistics. Only with NDA approval can drugs be marketed in the US. At the same time, in order to track management, FDA assigns an NDA number to all NDA.

A generic drug application is called a brief new drug application because it does not require animal tests (pre-clinical research) and human test (Clinical Research) data to prove the safety and effectiveness of generic drugs. Instead, generic drugs require sufficient scientific research to prove the bioequivalence of drugs (e.g., the performance of the original drug). ANDA should be submitted to the drug evaluation and Research Center (CDER) of the FDA generic drug (non-patent medicine) office, and ANDA includes information for the review of the CDER and the final approval of the generic drug. Once ANDA is approved for production and sale, the applicant can provide a safe, effective, but cheaper alternative to the public.

OTC refers to drugs that can be obtained without prescription. From the treatment of acne drugs to diet pills, there are more than 80 kinds of OTC drugs. As with prescription drugs, CDER needs to review OTC drugs to ensure that OTC drugs have a label that can be tracked effectively, and that the drug is more beneficial to the public than the disadvantages.

BLA refers to a submission of specific information containing production processes, chemistry, pharmacology, clinical pharmacology and medical effects. If the materials provided are in line with the requirements of FDA, the application will be approved and issued to the relevant products for sale.

BOC Sciences has decades of experience in preparing, compiling, reviewing and publishing electronic drug listings, labeler code registrations, structured product labeling, drug establishment registration and generic drug firm self-identification (GDFSI) files. For registration and submission of your pharmaceuticals, we provide you with services as follows:

  • Preparation, submission and modification of IND and CTA
  • Preparation, submission and modification of NDA, BLA, MAA and ANDA
  • Preparation and submission of the annual report
  • Original submissions to FDA and global regulatory agencies
  • Lifecycle submissions to FDA and global regulatory agencies
  • Regulatory dossiers under maintenance and lifecycle management
  • Regulatory publishing deliverables for a single, global biopharmaceutical client
  • Clinical study reports (CSRs) published
  • Electronic drug listing and establishment registration submissions

Moreover, during the review process, BOC Sciences will prepare and respond to the enquiries from the health department as required and provide the necessary regulatory support until the application is formally approved. After approval, BOC Sciences will maintain your IND/CTA application or sales license through the following services. Learning how our outsourced publishing solutions ensure quality and eliminate your regulatory publishing overhead costs, please contact us for your inquiry.

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