Helping companies around the world navigate the regulatory maze

Regulatory Maintenance of Approved Products

Navigating regulatory challenges through the entire life cycle takes expertise and experience. Our team can manage them, freeing you for innovation.

Regulatory teams are often overwhelmed with balancing priorities between Research and Development and associated tight deadlines and managing ongoing support of approved products. These conflicting activities can result in a lack of focus on company priorities and risk falling behind on marketed product regulatory submission deadlines, on-going requirements, and supply chain and compliance initiatives. .

Post-approval regulatory maintenance activities, submissions, and publishing are time-consuming, difficult to maintain, and often impede resources that can be utilized elsewhere. To properly conduct Post-Approval Maintenance (PAM), a company needs resources and personnel it might not have.

Mapi can help you expedite the regulatory process

Mapi works with regulatory agencies in over 60 countries, and has over 30,000 submissions since 2006. Our full-service regulatory team consists of 120 consultants and advisors, including regulatory executive and director-level staff members averaging 15-35 years in Product Full Life Cycle Expertise.

Mapi can help you with both marketed product initiatives and routine, but required, regulatory activities, like:

  • new therapeutic indications
  • product safety / labeling changes
  • manufacturing / packaging site changes
  • drug formulation, manufacturing process, and testing changes

The associated submissions can be as simple as regulator notifications to as complex as requiring regulator prior approval. Tracking, writing, and publishing these submissions can be a time-consuming ordeal for your Regulatory Affairs Department. We can provide the attention and regulatory maintenance your marketed products need and free your staff to focus on new products.

Let Mapi’s regulatory expertise work for you

Mapi’s Strategic Regulatory Services team can help you with both existing and new product regulatory submissions. We have the expertise to interact with regulatory agencies worldwide to prevent or resolve issues, and our regulatory experience can help you reduce overall regulatory costs per submission.

Post-approval regulatory maintenance requirements are often neglected for marketed products. Creating a backlog can be avoided by allowing our team to focus on existing products’ activities for you. This enables your in-house team to focus on new products.

In international markets, keeping up with the yearly changes involved in the increasingly diverse international regulatory process can be daunting. Our team of international regulatory experts can give you the peace of mind of knowing that your products are being looked after.

Expertise

Our team knows regulatory agencies and is highly skilled in obtaining approvals ranging from therapeutic changes to smaller chemical, manufacturing, and testing or site changes.

Experience

We have prepared over 30,000 high-quality submissions for regulatory agencies around the world.

Global Reach

We have filed in 63 countries and have regulatory expertise personnel located in North America, and Europe, as well as an expanding presence in India.

Established Products

We understand and respect established on-the-market products and the revenue they bring your company. We aim to free your staff from their regulatory activities and allow your staff to focus on your development products.

One-Stop Shop

We remove unnecessary reliance on multiple small regulatory providers.

Request a consultation with an Strategic Regulatory Services expert