Pharma 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.

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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 USA (USFDA)

The U.S. Food and Drug Administration (FDA) is a federal agency under the Department of Health and Human Services, responsible for safeguarding public health by regulating a wide array of products. These include food, drugs, medical devices, cosmetics etc. The Center for Drug Evaluation and Research (CDER) is a US FDA division which monitors the drugs in Food, drug and cosmetic Act.

Classification of Pharmaceuticals in Japan

The pharmaceutical drug products in US 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.

Further one more classification is there that is-

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)

It is submitted after the success of the pre-clinical trial and now the applicant is moving forward for clinical trials in humans. IND generally contains the protocols, manufacturing, chemistry, toxicology and pharmacology information.

The approval process includes the submission of an IND application to FDA, then FDA will forward it to the review team. Within 30 days of submission of IND, the review team will give its decision whether to start clinical trials or not. Then within 60 days of positive response the applicant must submit the clinical trial reports. The applicant has to organize a meeting one-month prior to the end of phase II trials.

Submission process for New Drug Application (NDA)

The NDA is only filed after the three phases of clinical trials are completed. The preclinical, clinical data and risk benefit analysis are reviewed by the Centre for drug evaluation and research.

During the submission of NDA, FDA requires two copies- archival and review copy.

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)

For the generic drugs, the Office of Generic Drugs (OGD) reviews and evaluates the generic drug’s safety, effectiveness and quality.

Types of abbreviated new drug application approval-

Full approval- when all the patents for the reference listed drugs are not available or are expired.

Tentative approval- if the FDA is satisfied with quality, safety and efficacy. However, due to existing patents and/or exclusivity rights, the product cannot be marketed in the United States until these protections expire.

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 offers a range of services to assist pharmaceutical companies with 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