Product Registration
Navigating the complex landscape of pharmaceutical product registration across multiple countries requires expertise, experience, and attention to detail.
At Sovvaka, we provide comprehensive product registration services to help you navigate regulatory requirements efficiently, ensuring your products reach markets faster while maintaining full compliance.
Product Registration Process
Our streamlined product registration process is designed to navigate regulatory complexities efficiently while ensuring compliance with all requirements.
Initial Assessment
We review your product and target markets to identify regulatory requirements and potential challenges.
Documentation Preparation
Our team prepares all necessary documents, including CTDs / ACTDs, product dossiers, and market-specific paperwork.
Submission & Follow-up
We submit your applications to the relevant authorities and follow up promptly to address any queries.
Approval & Maintenance
Once approved, we support ongoing registration maintenance, including renewals and updates, to ensure uninterrupted market access.
Why Choose Our Registration Services
Our product registration services offer numerous advantages that help you navigate regulatory complexities efficiently and effectively.
Global Expertise
Our team has extensive experience with regulatory requirements across Africa, Europe, and South America, ensuring smooth registration processes.
Time Efficiency
Our streamlined processes and regulatory expertise helpreduce registration timelines, allowing faster market entry for your products.
Compliance Assurance
We ensure all submissions meet the highest standards of compliance, minimizing the risk of delays or rejections.
Local Representation
We provide local regulatory representation in multiple countries, fulfilling requirements for local presence.
Post-Approval Support
Our services extend beyond initial registration to includerenewals, variations, and ongoing regulatory maintenance.
Strategic Planning
We develop customized registration strategies that align with your business objectives and market entry priorities.
Registration Across Multiple Markets
We provide product registration services across diverse markets, each with unique regulatory requirements and processes.
Africa
We navigate the diverse regulatory landscapes across African countries, including harmonized regional systems like the African Medicines Regulatory Harmonization (AMRH) initiative.
Europe
Our services cover European Medicines Agency (EMA) procedures as well as national procedures for EU and non-EU European countries.
South America
We handle registrations with ANVISA in Brazil, ANMAT in Argentina, INVIMA in Colombia, and other South American regulatory authorities.
Ready to Register Your Products?
Contact our regulatory experts today to discuss your product registration needs and discover how we can help you navigate complex regulatory requirements efficiently.
Our Registration Expertise
- Pharmaceutical products
- Medical devices
- Cosmetics and personal care
- Dietary supplements
- Veterinary products
- Nutraceutical products