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Strategic Regulatory Partner for Success in USA
Greetings from
Pharma Wizard USA Regulatory Services
The United States stands as an industry hub for the Life Sciences sector. With continuous innovation and growth, the country showcases significant potential for foreign medicinal productsā and medical devices manufacturers. As a well-established regulated market, the U.S. obliges manufacturers to adhere to the United States Food and Drug Administrationās (US FDA) stringent guidelines for compliant market entry. However, given the countryās dynamic Regulatory landscape with respect to registration procedures, technological advancements, and GxP best practices, keeping pace with continuous updates and compliant procedures might be challenging for foreign manufacturers.
Headquartered in New Jersey, USA, and having proven expertise in the U.S. Regulatory affairs, Pharma Wizard assists manufacturers to navigate the ever-evolving and stringent Regulatory procedures. Pharma Wizardās Regulatory services in the United States span across following product categories such as:
Headquartered in New Jersey, USA, and having proven expertise in the U.S. Regulatory affairs, Pharma Wizard assists manufacturers to navigate the ever-evolving and stringent Regulatory procedures. Pharma Wizardās Regulatory services in the United States span across following product categories such as:
Industries We Serve in USA
- Medicinal Products
- Medical Devices
- Cosmetics
- Food Supplements
- Chemicals
Medicinal Product Regulatory Support in USA
Pharmaceutical market in the United States of America (USA) is considered the best for its established Regulatory framework. The US Food and Drug Administration (US FDA) regulates the manufacture, import, distribution and marketing of pharma products in the country. The term pharma in the USA overarches numerous products and each of them possess a different approach to obtain market authorization. Pharmaceutical products in the country must be registered with the FDA through New Drug Application (NDA) for an Investigational New Drug (IND), Abbreviated New Drug Application (ANDA) for a generic drug, and through Biologics License Application (BLA) for a new biologic product.
Medical Devices Regulatory Support in USA
The United States of America (USA) is renowned for being a highly regulated market for Medical Devices, with well-defined registration pathways and requirements. The initial medical device regulations of the U.S. date back to 1976 and have evolved over time. They are regulated by the Center for Devices and Radiological Health (CDRH) under the Food and Drug Administration (FDA). Pharma Wizard has helped multiple device manufacturers to comply with the US FDA medical device registration process.
Cosmetics Regulatory Support in USA
Pharma Wizard, with a team of Qualified Regulatory experts, provides Cosmetics regulatory services in the USA such as Product Classification, FDA Cosmetic Claims Review, and Cosmetic Label Review as per the FDA Cosmetic Labeling Requirements, which are crucial for the establishment of Cosmetics in the USA. Headquartered in the USA, Pharma Wizard assists Manufacturers with quick Market Access based on Product Type. Pharma Wizard helps in aligning with the FD&C Act and MoCRA, and extends Post-Marketing Surveillance support for cost-effective Adverse Event Tracking and Reporting.
Food Supplements Regulatory Support in USA
The United States (US) is a compliance-based market for food and dietary supplements. The products are regulated by the Federal Register and the Code of Federal Regulations (CFR), Title 21, which serves as the legal authority of the US Food and Drug Administration (USFDA). Food and dietary supplements do not require pre-market approval, but the USFDA has a strict regulatory policy for evaluating these products through adverse event monitoring and research. Manufacturers of novel products and novel ingredients are required to submit a pre-market notification to the USFDA via the Generally Recognized as Safe (GRAS) notification and the New Dietary Ingredient Notification (NDIN) process.
Pharma Wizard supports manufacturers in preparing GRAS and NDIN submissions, ensuring full alignment with USFDA requirements for a compliant and efficient market entry.
Pharma Wizard supports manufacturers in preparing GRAS and NDIN submissions, ensuring full alignment with USFDA requirements for a compliant and efficient market entry.
Chemicals Regulatory Support in USA
Handling chemical products to minimize the risk to human beings and the environment is challenging. Many countries, including the USA, incorporate complex Regulatory processes to adhere right assessments for potential hazards in the chemical products for humans and the environment during production, processing, and distribution. In such scenarios, manufacturers must consider the GHS frameworks and information on various country-specific approaches for the risk management of chemical products.
Pharma Wizard Offerings
- Strategic Regulatory Consulting
- Regulatory Roadmap for Market Access
- Regulatory Affairs & Regulatory Intelligence
- Registration Pathways and License Management
- Lifecycle Maintenance: Variations, Renewals, Notifications
- Regulatory Publishing and Submissions
- Regulatory Labeling & Artwork Pack Management
- Medical and Scientific Writing
- Compliance Audit and Validation
Pharma Wizard Advantages
- Expert Regulatory team with proven global RA expertise
- Strong regional presence
- Proactive and collaborative approach
- Quick turnarounds and faster time-to-market