Regulatory Affairs Services

Navigate Regulatory Complexity with Confidence  

At IntraHub, we recognize that regulatory affairs are the backbone of a successful pharmaceutical business. Whether you are developing new products, expanding into new markets, or maintaining product compliance, we provide end-to-end regulatory services designed to simplify complex regulatory processes and position your products for success.

Our Regulatory Affairs team brings unmatched local expertise and deep knowledge of international guidelines to help pharmaceutical companies confidently manage product registrations, regulatory submissions, and post-marketing obligations.

Our Regulatory Affairs Solutions 

Product Registration & Licensing

We manage the entire lifecycle of product registration, from dossier preparation and submission to regulatory follow-ups and license maintenance. Whether for pharmaceuticals, biologics, or medical devices, we ensure your products meet the specific regulatory requirements of local and other regional or international authorities. We help you:

• Obtain product licenses and marketing authorizations (MA)
  
  
• Handle registration variations, renewals, and amendments
  
  
• Facilitate post-approval obligations efficiently

We take time to understand your products, markets, and challenges, crafting tailor-made solutions rather than generic templates.

Regulatory Submissions & Communications

IntraHub serves as your reliable bridge with regulatory agencies. We handle all forms of submissions, including initial product dossiers, variations, renewals, and response to queries. Our team ensures your submissions are accurate, complete, and in line with current regulatory expectations. 

Dossier Compilation & Review

Our experts prepare high-quality Common Technical Documents (CTDs) and other dossier formats in line with regulatory guidelines. We help you compile, review, and organize technical, non-clinical, clinical, and quality documentation to secure timely approvals.

Trademark Registration

Your brand identity is as important as your regulatory compliance. We assist with trademark registration and protection, a key requirement for pharmaceutical product registration, helping you safeguard your brand assets in the markets.

Regulatory Intelligence & Strategy

We actively monitor the evolving regulatory landscape in Nigeria, West Africa, and internationally to provide timely insights and recommendations. Our team helps you:

• Anticipate regulatory changes
  
  
• Adapt your regulatory strategy
  
  
• Avoid delays or non-compliance
  
  
• Strengthen your competitive advantage

Why IntraHub for Regulatory Affairs?

• Comprehensive Expertise: We manage every aspect of regulatory compliance, from initial submission to post-market surveillance.
  
  
• Customized Solutions: Tailored regulatory strategies designed to meet the unique needs of your business and products.
  
  
• Regulatory Compliance: Ensuring compliance with local, and other key regulatory authorities.
  
  
• Streamlined Processes: Efficient handling of regulatory documentation and faster market entry