PROCEDURES INVIMA
Proceedings before the INVIMA
Comprehensive management of health records, certificates and authorisations before the INVIMA
ON THE INVIMA
What is the INVIMA?
The National Institute of for Drug and Food Surveillance (INVIMA) is the regulatory authority of Colombia charged with protecting the public health through the monitoring and control of medicines, medical devices, food, cosmetics, alcoholic beverages, natural products, and other products that may affect the individual and collective health.
All companies that want to market products health in Colombia must obtain the medical records and authorizations before the INVIMA. Our team of Pharmaceutical Chemicals Lawyers accompanies you every step of the regulatory process.
- Drugs and biological products
- Medical devices and biomedical equipment
- Cosmetics and hygiene products
- Food and drinks
- Natural products and dietary supplements
- Reagents diagnostic in vitro
OUR SERVICES BEFORE THE INVIMA
Formalities that we Manage
Health Records
Complete management of health care records new to the INVIMA
- Drugs
- Medical devices
- Cosmetics
- Food
Renewals
Timely renewal of health records next to overcome
- Analysis of validity
- Updated documentation
- Filing timely
Modifications
Processing of modifications to the health records of existing
- Manufacturer changes
- Update of labeling
- Changes in composition
Certifications BPM
Certificates of Good Manufacturing Practices
- Inspections
- Improvement plans
- Certification national and international
Certificate CCITE
Certificate of Lack of Reports on the Trafficking of Narcotic drugs
- Controlled substances
- Precursor chemicals
- Ministry of Justice
Health Surveillance
Accompaniment in the processes of monitoring and control of the INVIMA
- Inspection visits
- Health measures
- Penal proceedings
OUR PROCESS
How Do We Work?
Initial Consultation
We evaluate your case and define the regulatory strategy
Documentation
Prepare and review all technical documentation and legal
Filing
We present the proceedings before the INVIMA, with follow-up
Follow-up
We monitor the process and cater to requirements
Approval
We obtain the favorable resolution and deliver documentation
500+
Records Managed
30+
Years of Experience
98%
Approval rate
100+
Business Consultancy
FREQUENTLY ASKED QUESTIONS
Important Information
How long is a health record?
The time varies depending on the type of product. New drugs can take between 6 and 12 months, while cosmetics and food tend to have shorter times of 3 to 6 months.
How much does a process before the INVIMA?
The rates of the INVIMA vary according to the type of procedure. In addition to the official fees our professional fees depend on the complexity of the case. Contact us for a custom quote.
Can you manage procedures for foreign companies?
Yes, we represent international companies before the INVIMA. We act as your legal representative in Colombia for all the paperwork necessary regulatory.
What documents do I need to start the process?
The documentation varies according to the type of product and process. In your initial consultation, we evaluate your case and provide you with a complete list of specific requirements.
Do you need to manage a process with the INVIMA?
Contact us for a free initial consultation about your specific case. Our team of Pharmaceutical Chemicals Lawyers will provide you with the best regulatory advice.
