In today’s competitive environment, reducing time to market is important to the success of a product and, therefore, to the company. The proper conduct of its regulatory activities is of considerable economic importance to a company. Our team of experts offers a wide range of Regulatory Affairs consulting services for pharmaceutical products and medical devices.
What we offer
- Preparing and submitting your applications for pharmaceutical establishment registration/license and transfer of facilities.
- Preparing and submitting applications for addition of locations for drug establishment’s warehouse.
- Managing applications for amendments to registration/license information.
- Technical Management service for Pharmaceutical Establishments.
- Reviewing and designing regulation-compliant labeling for medical devices, pharmaceutical and sanitary products.
- Submitting inquiries to Regulatory Authorities regarding import and marketing issues.
- Elaboration of applications for an Exceptional Permit to import pharmaceutical products, medical devices and sanitary products.