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Pharma Regulatory Strategy Consulting Company
Simplifying Pharma Regulation
Rexllance Your Regulatory Partner
Your one stop solution for PHARMA consultant.
Effortless compliance, every step of the way.
Expert guidance for pharma compliance.
Welcome to Rexllance
At Rexllance, we don't just provide consultingβwe partner with you to achieve regulatory excellence.
Our mission is to simplify the complexities of pharmaceutical regulation, guiding you through every step with precision, expertise, and a commitment to your success.
With Rexllance by your side, you can confidently navigate the regulatory landscape and bring your products to market with speed and compliance.
Our Services
Comprehensive regulatory solutions tailored to your pharmaceutical needs
Strategic Regulatory Consulting
Craft customized regulatory roadmaps aligned with your goals.
Product Registration & Licensing
Streamline your product registration from dossier preparation to final approval with expert guidance.
Clinical Trial Support
End-to-end support for clinical trials, from protocol design to regulatory submissions and compliance.
Quality Assurance
Meet highest standards with comprehensive QA services.
Pharmacovigilance
Patient safety through adverse event monitoring and reporting.
Regulatory Intelligence
Stay ahead with global regulatory monitoring and timely insights to keep you informed and prepared.
Areas of Rexllance
At Rexllance, we deliver tailored regulatory solutions across a wide spectrum of pharmaceutical and healthcare domains. Whether you require comprehensive end-to-end support or assistance with specific regulatory challenges, our expertise ensures your projects are handled with precision and care.
API (Active Pharmaceutical Ingredients)
Regulatory support for active pharmaceutical ingredients across all development phases.
Investigational New Drugs (IND)
Comprehensive IND submission and regulatory strategy for investigational drug applications.
New Drugs
Complete regulatory support for new drug applications and approvals.
FDC (Fixed Dose Combinations)
Navigate fixed dose combination regulations with expert guidance.
Vaccines & Biotech Products
Specialized regulatory pathways for vaccines and biological products.
Veterinary Product Registration
Complete regulatory support for veterinary pharmaceutical products.
Bioequivalence (BE) & Clinical Trials (CT/NDCT)
Clinical trial applications and bioequivalence study support.
Post Approval Changes (PAC) Submissions
Post-approval change submissions and lifecycle management.
Written Confirmation (WC) Certificate
Secure written confirmations and regulatory certifications.
NIB, IPC and CDTL Testing
Near-infrared spectroscopy testing and validation services.
SEC Presentations
Scientific advisory committee presentation preparation and support.
ANDA Registration for APIs and Finished Products
Abbreviated new drug application submissions for generics.
Cosmetics (Import Registration)
Import registration and compliance for cosmetic products.
Medical Device and IVD (Import Registration)
Medical device and in-vitro diagnostic registration services.
Blood Bank Registration
Regulatory compliance for blood bank operations and products.
Periodic Safety Update Reports (PSUR)
Regular safety reporting and pharmacovigilance documentation.
SAE Submission
Serious adverse event reporting and regulatory submissions.
Ethics Committee Registration
Ethics committee setup and regulatory registration support.
SUGAM Registration
SUGAM portal registration and compliance management.
Regulatory Intelligence
Strategic regulatory intelligence and market access insights.
Licensing with MH&FW (Human Resources, Department of Biotechnology, etc.)
Government licensing and departmental approvals coordination.
Other Product Categories (Ayush, Supplements, Nutraceuticals)
Regulatory solutions for alternative medicine and nutritional products.
FSSAI
Food safety and standards authority compliance and licensing.
NPPA
National pharmaceutical pricing authority submissions and compliance.
Latest Updates
