One-Stop For All Your Regulatory Needs. We empower your innovation by navigating the intricacies of global regulations, enabling you to bring safe and effective solutions to market efficiently.
A specialized consultancy with a team of seasoned professionals with extensive experience dedicated to guiding clients through complex regulatory landscapes
We are passionate about helping our clients achieve their goals while maintaining the highest levels of regulatory compliance and ethical standards. We partner with you to ensure your innovations reach their full potential.
Our team of experts provides strategic guidance and practical solutions to ensure your products and processes meet the highest standards of compliance. We understand the challenges of navigating the evolving regulatory environment and are committed to providing our clients with comprehensive support.
Years of Experience
Clinical Trials Supported
Industry Sectors
Publications
Regulatory Excellence
Comprehensive regulatory support across four key industry sectors
Regulatory pathways for novel therapies, genetic engineering, bio-based products, and biosimilars including GMO and gene editing regulations.
Compliance with food safety standards, agricultural biotechnology regulations, sustainable practices, and novel foods approvals.
Approval processes for animal health products, feed additives, veterinary medical devices, and veterinary pharmacovigilance.
Drug development, clinical trials, market authorization for biopharmaceuticals, biologics, and biosimilars.
Comprehensive regulatory solutions to ensure your success
Regulatory pathway development, gap analysis, due diligence, lifecycle management, and global regulatory intelligence.
Learn MoreCompilation and submission of regulatory dossiers, technical writing, labeling compliance, and clinical trial applications.
Learn MoreGMP, GLP, GCP compliance, quality management systems, pharmacovigilance, and food safety compliance.
Learn MoreAgency interactions, regulatory negotiation, advocacy, and comprehensive training programs.
Learn MoreBiosafety, biosecurity, GLP, GMP, GCP training, webinars, hands-on experience, and certificate courses.
Learn MoreMedical devices, food additives, pesticide registrations, export/import compliance, and data privacy solutions.
Learn MoreProven track record of successful regulatory support and international partnerships
Global Partnerships
Connect with us to learn more about our work
M42/1, Medical Devices PArk, Sultanpur
Petancheru, Medak, Telangana, India
502319
info@genentechbio.com