Regulatory Services
With the rapid development of pet drugs, the regulatory landscape has become increasingly stringent. A reliable strategic partner is key to rapid market entry for pet drugs. Protheragen Vetivio boasts a robust team of regulatory experts dedicated to providing one-stop regulatory services throughout the entire lifecycle of your pet drugs. From the initial design phase, we engage early to craft the most efficient registration strategies, mitigating potential risks and significantly accelerating time-to-market.
If you have any needs, please do not hesitate to contact us. With Protheragen Vetivio, regulatory success is built in from the start.
Our Services
Protheragen Vetivio's regulatory team has in-depth knowledge of the regulatory requirements of major global pet drug regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), etc. Therefore, we provide one-stop regulatory services throughout the entire pet drug development cycle, from early development to post-marketing.
Global Registration Strategy Development and Consultation
Market Access Planning: Develop optimal registration strategies tailored to your target markets.
Regulatory Feasibility Assessment: Evaluate the regulatory viability and potential risks of projects during early development stages.
Regulatory Gap Analysis: Compare regulatory requirements across different target markets to design efficient registration pathways.
Communication with Regulatory Authorities: Assist in preparing meeting materials and represent clients in effective communications with regulatory agencies.
Registration Dossier Preparation and Submission
eCTD/CTD Dossier Support: Prepare high-quality, comprehensive registration application documents in strict compliance with FDA eCTD, EU CTD, and other regional formatting requirements.
Quality (CMC) Documentation Support: Provide end-to-end drug development and quality study support, and author GMP-compliant CMC documents covering manufacturing processes, quality control, stability studies, and more.
Non-Clinical Documentation Support: Review, consolidate, and submit non-clinical study reports and summaries in accordance with GLP standards.
Clinical Documentation Support: Review, consolidate, and submit clinical study reports and summaries compliant with GCP standards.
Dossier Submission and Management: Represent clients in the electronic or paper-based submission of dossiers to target regulatory agencies and manage subsequent documents.
Post-Market Regulatory Maintenance
Change Management: Assess the regulatory impact of changes in manufacturing processes, quality standards, facilities, labeling, etc., and prepare and submit variation applications.
Annual Reporting: Assist in preparing and submitting annual reports as required by the FDA or other periodic update reports mandated by relevant regulatory bodies.
Re-registration/Renewal Support: Manage the renewal and extension of marketing authorizations for products.
Pharmacovigilance: Provide pet drug safety monitoring and adverse event reporting services in compliance with regulatory requirements.
Regulatory Monitoring and Training
Regulatory Intelligence Monitoring: Continuously track updates and changes in regulations, policies, and technical guidelines across key global pet drug markets, providing timely alerts and analytical reports.
Customized Regulatory Training: Deliver specialized training sessions on pet drug regulations tailored to client needs.
Process of Our Services
Why Choose Us?
Professional Pet Drug Regulatory Team
Our regulatory experts possess deep knowledge of the unique regulatory requirements for pet drugs. We accurately anticipate potential approval challenges and design optimal strategies to mitigate risks, accelerating the market entry of your pet drugs.
Exceptional Document Writing Capabilities
We are proficient in eCTD/CTD formatting and regional documentation standards, ensuring every submission is characterized by complete data, sound logic, and standardized formatting. This minimizes approval delays caused by documentation quality issues.
Extensive Practical Experience
With a thorough understanding of regulatory details and technical guideline variations across different countries, we have successfully led marketing authorization applications for pet drugs in major markets such as the U.S. FDA-CVM, EU EMA, and the UK VMD, covering a wide range of chemical and biological drugs.
Client-Centric Collaboration Model
We reject the "one-size-fits-all" approach, offering tailored services based on your project stage, veterinary product type, target market, and budget. Each project is assigned a dedicated project manager to ensure smooth communication and timely responses.