Regulatory Affairs
Strategy & Gap Analysis Dossier Development Dossier Submission EU Support EAEU Support Authority Interaction & Scientific Advice Lifecycle Management Regulatory Intelligence Promotional Materials & Packaging Updates

Strategy & Gap Analysis

Having a solid regulatory strategy is essential to ensuring that your product reaches the market in the fastest possible time. With no plan in place, you'll have no way of anticipating potential problems or deadlines. Decades of combined knowledge and local expertise in regulatory consulting means that Biomapas can create a comprehensive strategy. We provide you with a solid strategy, take care of necessary paperwork, and allow you to predict key milestones confidently. 

Dossier Development

Scientists with PhDs in biomedical sciences, who have worked in the pharmaceutical business, clinical research organizations, or academic institutions, compose our medical content. In addition, medical Writers from Biomapas may assist you with creating documentation that is needed in clinical research, regulatory affairs, or for scientific reasons, among other things.

Dossier Submission

Throughout Europe, Biomapas offers local regulatory affairs assistance to customers in pre-approval and post-approval regulatory affairs.

It is the goal of our complete spectrum of Regulatory Affairs solutions to provide our customers with an outstanding level of support, help, and regulatory approvals. We use rapid, efficient, and cost-effective working methods to get the job done quickly and efficiently.

EU Support

We have assisted our clients in obtaining more than 150 Marketing Authorizations through National Procedures. Over the past few years, we have executed more than 1,000 regulatory submissions on our clients' behalf. Additionally, we were/are involved in more than 25 marketing authorization processes for medical products, including centralized, decentralized, and mutual recognition procedures.

EAEU Support

If you are interested in marketing your medical product in the Eurasian Economic Union's (EAEU) rapidly expanding pharmaceutical industry, Biomapas is the ideal partner for you. The EAEU is an exciting market for drug registration. Our specialists are eager to discuss the various paths for drug registration in the Eurasian Economic Union and provide guidance on aligning already registered medicines' dossiers with the new criteria. 

Authority Interaction & Scientific Advice

As the regulatory environment becomes more complicated, Biomapas' specialists assist our customers in navigating it. We assist you from the planning and implementation of early-stage research through approval and beyond. To help you get the most from Scientific Advice meetings, our experts can prepare questions that deliver the answers you need, interpret agency responses, and rehearse meeting scenarios.

Lifecycle Management

Experience in renewing and modifying pharmaceutical products and other aspects of medical product lifecycle management is essential to achieving corporate objectives. To help you reach them, we offer different solutions to our clients based on their portfolios ranging from small molecules to ATMP's and Medical Devices.

Regulatory Intelligence

With the help of Biomapas' Regulatory Intelligence services, you can create a viable drug development program, conduct efficient trials, and develop a sound commercialization plan. We combine our knowledge and expertise with publically accessible data and experience-based data sources to create a solid strategy that will save you time and money. Shortly, we facilitate you in making strategic decisions and gaining an edge in a competitive market.

Promotional Materials & Packaging Updates

Pharmaceutical firms are required to comply with health authority regulations on promotional materials and activities that they participate in or support with the intent of influencing the prescription and usage of a medicinal product. Therefore, all your promotional materials should comply with the international and national standards established by the European Union (EU) and local health authorities for marketing medicines.