Specialized support from experts who know your industry.
Our dynamic regulatory affairs group is built on decades of practice in the region and is committed to keeping pace with discovery and innovation. Our client teams are led by experienced attorneys and specialized practitioners and include, as appropriate to the client and its industry, pharmacists, agricultural consultants, and other regulatory specialists. We guide our clients through the layers of formal and informal rules, policies, and procedures, and help our clients forge constructive relationships with regulatory authorities.
We assist with the registration and prosecution of pharmaceuticals, biotechnology products, food and food supplements, narcotic and psychotropic substances, medical devices, cosmetics, hazardous substances, and animal and crop health products with national food and drug agencies and agricultural regulators.
Our practice spans the following disciplines:
- Clinical trials and consumer testing
- Registration with public health authorities
- FDA import, export, and manufacturing licenses
- Crop care registration with agricultural regulatory authorities
- Animal, aquatic, and hazardous substance registration
- Import, export, and manufacturing licenses
- Holding licenses
- Regulatory compliance and maintenance
- Labeling and advertising clearance
- Intellectual property