Carlsbad Tech’s FDA Drug Approval Consultants

The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. The FDA regulates and supervises food safety, tobacco products, dietary supplements, prescription and over-the-counter drugs, biopharmaceuticals, vaccines, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods and veterinary products.

Most compounds or drugs have to go through a stringent and elaborate process to become an approved drug. To reach the U.S. market, all medical products must comply with the applicable rules and laws developed and enforced by FDA. An FDA Drug Approval Consultant can help with the development of a generic drug and create a program for launching the product. Our experienced and skilled consultants offer consulting services to pharmaceutical, diagnostics, biotech, medical device and related companies.

An FDA Drug Approval Consultant helps in drafting regulatory submissions for firms before submitting it to the FDA. A consultant can advise on analytical methods, stability and other issues involved in the approval process. In other words, a consultant facilitates the entire FDA approval process for a new drug. FDA Drug Approval Consultants assist clients with the required compliance procedures and help facilitate the launch of a medical drug or product in the market within the shortest possible period of time. Our team of experts will help facilitate innovation, evade competition and repurpose existing drug products, if required.

Our services include:

• Abbreviated New Drug Application (ANDA)
• Drug Master File submission (DMF)
• Meeting support
• Documentation
• Labeling assistance
• Assistance to meet post-approval requirements
• cGMP
• US agent

We provide consultancy for startups, mid-sized and large multinational companies. Our Drug Approval Consultants have set up a large number of quality systems to meet FDA’s requirements (cGMP) for new companies and products. Our planning, execution and submission process is unrivalled in the industry. We ensure affordability and promptness at all stages of the drug approval process. Our consultants work with you to obtain and maintain compliance and also meet your marketing milestones. Contact us today for a quote.