Welcome to Regal Intel, your premier partner in regulatory consulting for the BioTech industries. We provide expert guidance and tailored solutions to help you navigate the complexities of global regulations, achieve compliance, and bring your innovative products to market efficiently and effectively.
We specialize in Global Regulatory Registration, Accreditation, Certification and Remediation:
Global Registrations:
We have extensive experience in managing clinical trials and global product registrations, including navigating complex procedures for marketing authorization and product licensing in various countries.
Key Services:
Industries Served:
Regal Intel was founded in 2001 on the principle of providing unparalleled regulatory expertise to pharmaceutical and medical device companies navigating an increasingly complex global landscape. With years of experience in the industry, our team recognized the critical need for a consulting partner that not only understands the intricacies of regulations but also offers practical, results-oriented solutions. From our inception, we have been dedicated to empowering our clients to achieve and maintain compliance, ensuring the safety and efficacy of their products and facilitating their success in the market.
Our Mission
To provide exceptional regulatory consulting services that enable biotech (pharmaceutical, biologic, and medical device) companies to confidently navigate global regulations, ensuring the highest standards of quality and safety for their products and the patients they serve.
Our Vision
To be the leading and most trusted regulatory consulting firm, recognized for our deep expertise, innovative solutions, and unwavering commitment to client success in the life sciences industry.
Our Values
Partnering with Regal Intel means gaining a strategic advantage in the complex world of regulatory compliance. We offer:
Regal Intel provides comprehensive consulting services to help your organization achieve and maintain compliance with key ISO standards:
Regal Intel offers specialized expertise to navigate the regulatory requirements of key international health authorities:
Receiving a warning letter from regulatory agencies like the FDA or EMA can be a serious concern. Regal Intel offers specialized expertise to help companies effectively respond to and remediate these critical issues. Our systematic approach includes:
Our goal is to help you minimize potential business disruptions and reputational damage by guiding you through each step of the warning letter remediation process, ultimately leading to a successful resolution and the restoration of regulatory compliance.
Navigating the complexities of importing and exporting pharmaceuticals and medical devices requires adherence to numerous regulations. Regal Intel provides specialized services to ensure your company's international trade operations are compliant and efficient. Our support includes:
We help companies streamline their international trade operations, ensuring full regulatory compliance and facilitating the global distribution of their products.
Biologics, including vaccines, blood products, and gene therapies, are subject to unique regulatory challenges. Regal Intel offers specialized expertise in navigating the complex regulatory landscape for biologics, including requirements related to manufacturing, testing, and clinical trials. We help your organization meet the specific demands of regulatory authorities worldwide, ensuring the safe and effective development and distribution of your biologic products.
The pharmaceutical industry operates under stringent regulations to ensure the safety, efficacy, and quality of medications. Regal Intel understands the complexities of drug development, manufacturing, and approval processes. We provide expert guidance on navigating regulations from agencies like the FDA, EMA, NMPA, and others, ensuring compliance at every stage, from preclinical studies to post-market surveillance.
The medical device industry is characterized by a diverse range of products and increasingly complex regulatory requirements, such as the EU MDR and IVDR. Regal Intel provides comprehensive consulting services to medical device companies, assisting with ISO 13485 certification, risk management according to ISO 14971, biological evaluation as per ISO 10993, and navigating the requirements of regulatory bodies like the FDA, EMA, TGA, and others. We ensure your devices meet the necessary safety and performance standards for global market access.
Companion diagnostics (including personalized medicine), a subset of in vitro diagnostics (IVDs), play a pivotal role in modern healthcare by providing information that is essential for the safe and effective use of a corresponding therapeutic product. The increasing emphasis on personalized medicine and the growing complexity of combination products (including animal-origin free components) underscore the critical need for expert regulatory guidance. We help your organization with IND/IMPD filings, CTA/BLA filings, and facilitate approvals with strategic compilation.
The regulatory landscape for combination devices, which integrate two or more regulated components such as drugs, biologics, and/or medical devices, is governed by specific frameworks in both the United States, the European Union, and other global countries. We help navigate the complexity of the regulations and ensure a seamless registration process.
We assist in covering internal audits for specific criteria as defined and required by organizations and meet the important elements of compliance in internal processes. We assist in independent 3rd party audits with certified auditors and ex-FDA personnel to ensure that the organization processes are sustainable.