LIFE SCIENCES

We provide a complete technical-legal service in:

Regulatory Affairs

• We are trained to process each of our clients' requirements to obtain the Registration of new products, Re-registrations, Official Consultations, or Changes in the Sanitary Registry of Medical Devices, Pharmaceutical Products, Cosmetics, Biologicals, Health Products, Food, Beverages, Food Additives and Chemical Inputs before the corresponding Health Authorities.

• Controlled Products such as Psychotropic and Narcotic Drugs are subject to Sanitary Control.

• Medicinal Cannabis and its Derivatives. 

• Agrochemicals.

• We keep in touch with the Health Authorities and follow up on each process that we carry out. We seek success in each procedure, giving the importance and attention necessary to achieve the success, satisfaction, and loyalty of each of our clients.

Regulatory Intelligence

• We have a multidisciplinary team of professionals who offer a comprehensive solution and service for our clients in regulatory matters regarding national and international regulations so that they can comply with the current regulatory framework, through strategic and management consulting services.

Quality Management

• For Pharmaceutical Establishments for their Certification, Sanitary Authorization, Expansion, Relocation, and other procedures.

• Good Manufacturing Practices.

• Good Storage Practices.

• Good Distribution and Transportation Practices Qualification and Validation.

Pharmacovigilance and Technovigilance

• Design and preparation of the System of Good Pharmacovigilance and Technovigilance Practices in accordance with current regulations for the Detection, Evaluation, Compression, and Prevention of the adverse effects of Pharmaceutical Products, Medical Devices, and Health Products or any other problems related to them.

Training

• Training in Sanitary Regulation, the regulation is constantly changing, so it is important to be trained and updated. 

Translations

• Translation and specialized interpretation of English and Spanish.