Areas of Practice
Government
As government regulatory measures increase, it’s necessary to have a firm that is familiar with U.S. Federal Acquisition Regulations (FARs) and appropriate regulatory standards. Our team has procurement experience with the U.S. Government. We managed portfolios of $17M + of current assets and over $150M + in non-current assets with over 99.8% accountability.
NAICS CODES: 425110 (Business to Business Electronic Markets), 425120 (Wholesale Trade Agents and Brokers), 541614 (Process, Physical Distribution, and Logistics Consulting Services)
NGO
Providing honest supplies and services to those in need is part of what brings the very best out of our firm. We firmly believe that aid money should go towards those in need. Our team has experience running an NGO and takes great pride in good stewardship of generosity. Rest assured that your donations and grants provide what you need.
Private business
The internet, software, and technology are so pervasive that we can’t remember having ever lived without them. They make our lives simpler, but behind the curtain are fluctuating challenges in protection and monetization—challenges that our firm stays two steps ahead of. With the consistent introduction of varying revenue streams and distribution channels, the opportunity for profit grows, but so does the complexity. That’s where we come in. We’ll get your product where it needs to go.
Consulting
/ Allies
New Markets Strategies:
- Market vs Products Research (National and International)
- Analysis and Classification of Sanitary Registers in accordance with the applicable regulation
- Critical Route of the Products Pipeline
- Chronological Investment Proposal
- Search for options for Warehouse, Marketing and Distribution in Latin America
- Legal Services for Alliances (if required)
- Sanitary Registers of allopathic medicines fractions I, II, III, IV, V, VI, herbalists, vitamins and biotechnology and Medical Devices Classes I, II and III.
- Legal Opinions and Permits for Advertising Matters (labeling, campaigns, among others)
- Bioequivalence Studies (Stability Tests, Irritability, among others)
Outsourcing Regultatory Area:
- Audits, Diagnosis and Training of the Regulatory Area of labs and distributors
- Creation of Dossiers for Sanitary Registers of health supplies, pesticides and plant nutrients.
- Clinical protocols with validation by COFEPRIS
- Pharmacovigilance and Technovigilance Units (outsourcing or training of internal personnel)
- Health Registries of Vitamins, Pesticides, Pesticides, Fertilizers, and Medications and Medical
- Devices class I, II, II and Low risk
- Registration Procedures for Equivalence between agencies recognized by COFEPRIS
Alphanumeric key authorization - Consultation of classification of food supplements
- Import and Export Permits of any of the above
- Sanitary Responsible and Sanitary Registers Hosting of Medicines and Medical Devices
- Submission with the Authority, Process Monitoring and Prevention Resolution
Planning, review of documentation and creation of procedures for obtaining Licenses and Permits to open:
- Warehouses and Distribution Centers
- Laboratories* and Production Plants
- Pharmacies, Apothecaries and Drugstores
- Hospitals and Clinics
*Obtaining the Certificate of Good Manufacturing Practices (CBP in Spanish)
Other services:
• Legal and Fiscal Constitution of the Company
• Government sales
• Private Sales
• Generic Drug Development
• Patents and trademarks
• Recruitment and Selection of Specialized Personnel
• Other Legal Matters (in case any external signature is required)