Regal Intel: Your Global Regulatory Partner (2001-Present)
Since 2001, Regal Intel has guided pharmaceutical, biologic, and medical device companies through the complexities of global regulatory compliance. We provide comprehensive, end-to-end solutions, streamlining market access worldwide. Our expertise spans strategic planning, dossier preparation, and post-market surveillance. We specialize in global registrations, certifications (GMP, ISO 13485, MDSAP, Halal, Kosher), and regulatory submissions (FDA, EMA, NMPA). Our services include clinical/biological evaluations (CERs/BERs), SaMD guidance, and QMS implementation. We offer remediation for regulatory findings (FDA 483s, warning letters) and strategic intelligence for proactive compliance."
"Regal Intel ensures quality via supplier audits and Lean Six Sigma optimization. Our 'Regal Intel Verified' program enhances supplier credibility. We are your trusted partner, driving global success with expertise and a client-centric approach. We offer expertise in EU MDR and IVDR, and navigate the difficult pathways for 510(k), PMA, IDE, IND, NDA, and BLA submissions. We also provide support for postmarket surveillance, and help implement and maintain effective QMS and GDocP that meet global regulatory requirements. We provide expert analysis and response to FDA 483 findings, and assist with validation of non-product software."
"We handle import/export trade compliance, and help with Lean Six Sigma consulting. We assist with the complexities of combination products, and advanced therapies, and have expertise in radiopharmaceuticals. Our team also has expertise in cell and gene therapies, and we help with rare disease and priority review. We can assist with GMP, GDP, VAWD, and ICH standards adherence. We will help with your 3rd party audits, and mock FDA and Notified Body audits. We also provide Halal, Kosher, and Animal origin free certification. We will assist with supplier qualification. We are your trusted partner for
Company Details
- Employees
- 2
- Founded
- -
- Address
- Boston, Us
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Website
- https://www.regalintel.com
- Keywords
- Certified Quality Training, Global Product Registration, Global Regulatory Affairs, Global Quality, Warning Letter Remediation, Halal, Kosher, Animal Origin Free, Clinical Evaluation, Biological Evaluation, Regulatory Submissions, 510k, PMA, IND NDA ANDA, IND BLA, SaMD Submissions, Regulatory Intelligence, Supplier Quality Management, 3rd Party Audits, Internal Audits, Supplier Audits, Lean Six Signa.
- HQ
- Boston
Regal Intel Questions
Regal Intel's website is https://www.regalintel.com
Regal Intel's LinkedIn profile is https://www.linkedin.com/company/regalintel
Regal Intel has
2 employees.
View email and phone details for 2
employees at Regal Intel.
Regal Intel's industry is
Biotechnology Research
Regal Intel's top competitors are
Tobra Medical,
Isoform Oncology,
Regal International Trades,
Epibone, Inc.,
Tivic Health,
Advanced Solution,
Twist Bioscience,
Integrated Dna Technologies,
Mass Technology Leadership Council,
Regal International Ltd..
Regal Intel's categories are Biotechnology Research
Regal Intel's founding year is 2001
