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Pharmaceutical Regulatory Affairs Consulting Services in USA
Artixio provides Pharma Regulatory Affairs Consulting Services in the USA, covering the entire regulatory lifecycle—from strategy and registration to operational support and post-market maintenance for the pharmaceutical industry.
Services We Offer
Artixio has collaborated with over 50 global pharmaceutical companies, delivering strategic market entry for their products. With over 30 years of expertise in USFDA pharma regulatory affairs solutions, our team offers solutions across various therapeutic areas and drug innovations. As a trusted regulatory affairs company in United States, we support clients with both regional and international regulatory strategies.
Right from development to registration and post-approval support, Artixio provides comprehensive, integrated, regulatory and market intelligence–driven services across strategy, writing, dossier preparation, publishing, labeling, artwork, ad-promo, and regulatory information management. Our USFDA regulatory affairs consultant team for pharmaceuticals offers expert guidance to help you meet U.S. regulatory expectations efficiently and accurately.
Pharmaceutical Regulatory Affairs in the USA (USFDA)
Classification of Pharmaceuticals in USA
Pharmaceutical Products in USA are Classified in Two Categories
- Prescription drugs- these medicines can only be given with a prescription by a professional.
- Over the counter drugs- these are the medicines which do not require any prescriptions.
- Chemical compounds – these drugs are prepared by mixing chemicals in different or fixed proportions.
- Branded drugs
- Generic drugs
- Biologic drugs – these are therapeutic products like gene therapy, vaccines, recombinant products etc.
- Patented biologics
- Biosimilar
Submission process for Investigational New Drug (IND)
Submission process for New Drug Application (NDA)
In the process, firstly a Pre-NDA meeting is conducted which will address the content and format. After the pre-NDA meeting, the NDA is submitted. Within 60 days the FDA decides if it will accept the file to review. FDA will forward the file to CDER and they will review it and will decide if it is eligible for filing. If eligible, then it accepts it and forwards it to the FDA review team. The FDA will inspect the facilities to check that it is obliged with the regulations. Within 180 days the review team will submit it to CDER. If the FDA gets satisfied, then the FDA will issue the market authorization to sponsor.
Regulatory Process for Pharmaceuticals in USA (USFDA)
Procedure for ANDA approval
- The applicant must apply ANDA to FDA with the section 505(j).
- The regulatory team has to review the files and has to take a decision regarding the completeness of the application.
- Based on the review of the application, an Acceptance/Refuse to receive letter is issued.
Artixio’s Services for Pharmaceutical Product Registration in USA
Collaborate with Artixio’s USA Expertise
with Seamless Global Delivery
- Successful Approvals and Product Lifecycle Maintenance for 300+ products
- Diverse Products Experience across Complex Products Categories and Therapeutic Areas
- Strong Regional Expert with 30+ years of experience
- Proven Experience in End-to-End Product Value Chain from Concept to Commercialization
- Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
- ISO 9001:2015 quality standards governed services
- Customer focused, flexible services and solutions
- Flexible Business Model including project based, managed services and FTE staffing model
- Hybrid-Local-Centralized Support across Regulatory functions
FAQs
What is NDC (National Drug code)?
What is the timeline for drug approval?
How to report adverse events?
Where to find patent information?
Still Have Questions ?
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Publishing & Submission
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