Our services include regulatory activities for:
- Small Molecules
- Biotech/Biologics and Vaccines
- Medical Devices and Combination Products
- Regulatory Operations
We offer support in the strategic decision making process, management of individual and multiple interrelated projects, and supervision of regulatory, quality and production teams. Our capability to provide strategic input, and to apply macro and micro project and people management techniques gives the possibility to our clients to maintain the regular life-cycle of products and at the same time execute changes quickly and efficiently.
Our small and medium-sized enterprises (SME) qualification in EU enables us to use administrative, regulatory and financial benefits, e.g. reduced fees and easy access to EMA support.
Besides EU regulatory support, we can provide support for submissions worldwide. We offer multilingual and multicultural support for clients desiring to expand their presence on other markets or requiring to work with other cultures. We are fluent in English, Dutch, Russian, Ukrainian, Polish, German and Chinese.
Furthermore, we can provide support with GMP procedures, during roll-out and implementation, to resolve quality or manufacturing issues, to drive resolution of significant investigations related to production and/or product quality, and to ensure continuous regulatory compliance. We can also provide regulatory courses addressing a variety of subjects related to regulatory affairs, either standalone, or in combination with GMP training programs.