Procedures

Product Registration

Navigating the complex landscape of pharmaceutical product registration across multiple countries requires expertise, experience, and attention to detail.

At Sovvaka Global, we provide comprehensive product registration services to help you navigate regulatory requirements efficiently, ensuring your products reach markets faster while maintaining full compliance.

Our Process

Product Registration Process

Our streamlined product registration process is designed to navigate regulatory complexities efficiently while ensuring compliance with all requirements.

01

Initial Assessment

We conduct a thorough assessment of your product and target markets to identify regulatory requirements and potential challenges.

02

Documentation Preparation

Our experts prepare all necessary documentation, including Common Technical Documents (CTD), product dossiers, and market-specific requirements.

03

Submission & Follow-up

We submit applications to relevant regulatory authorities and actively follow up to address any queries or requirements promptly.

04

Approval & Maintenance

Upon approval, we help maintain registrations through timely renewals and updates to ensure continuous market access.

Benefits

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 help reduce 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 include renewals, variations, and ongoing regulatory maintenance.

Strategic Planning

We develop customized registration strategies that align with your business objectives and market entry priorities.

Markets

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.