Health Regulatory
IURISRED is an Ecuadorian law firm specializing in health regulatory law and legal advice on sanitary registrations before Ecuador's National Agency for Health Regulation, Control and Surveillance (ARCSA).
We protect your interests
Our health regulatory lawyers advise on sanitary registration processes in Ecuador, working closely with a specialized technical team of pharmaceutical chemists and professionals in chemistry, food science and agronomy, with in-depth knowledge of ARCSA requirements and procedures.
- Certifications
- Good Practices
- Legal Counseling
- Administrative Lawyers
- Chemical Technical Consultants
benefits
Benefits of regulatory compliance
Failure to comply with health regulations may entail fines and economic sanctions. Our advice will help you avoid these sanctions and protect your business.
Our services will help you ensure that your products meet the quality and safety standards necessary to protect the health of consumers.
Compliance with health regulations is fundamental to the image of the company. Our advice helps to improve the image and increase the trust of your customers.
Products requiring ARCSA sanitary registration
- Biological products
- Natural products
- Dental products
- Medical devices
- Biochemical and diagnostic reagents
Products requiring health notification
- Processed foods
- Food additives
- Cosmetics
- Hygienic products
- Nutraceutical products
- Homeopathic products
- Pesticide
Certifications
Advice and support for the preparation of applications for the issuance of certificates:
- Health records of medicines in general, biological medicines, natural products of medicinal use.
- Health records of medical devices, biochemical reagents, biomedical equipment.
- Compulsory health notifications of personal hygiene absorbents and hygiene products.
- Health notifications of processed foods and dietary supplements.
- Compulsory sanitary notifications Our services include the review of the technical dossier, the adequacy of labels according to the current regulations and other requirements that are necessary for these processes.
Technical and legal representation before ARCSA
Our legal team is highly trained to provide comprehensive solutions in health regulatory issues, special processes, legal technical representation against ARCSA, among others your company needs.
Our group of professionals specializing in technical and legal advice on health regularization issues, we are ready to make an accompaniment and provide the specialized advice that your company requires, if you plan to export your products to Ecuador
(593) 4 4632290
Judicial matters can be complicated, our experts are available to help you and inform you about aspects related to your topic.
IURISRED ABOGED & CONSULTORS
Services portfolio
- Preparation of application for registration or health notice
- Preparation of request for modification or extension
- Preparation of re-registration application
- Services of ownership or hosting of foreign health records
- Preparation of application for certificate requires or does not require registration
- Preparation of application for certified copying of sanitary registration
- Preparation of application for certificate of validity of sanitary registration
- Preparation of application for free sale certificate (CLV)
- Preparation of application for batch certificates
- Preparation of application for operating permit
- Preparation of technical consultation to the regulatory entity
- Preparation or revision of technical documents
- Advice to Implement Good BPA Storage Practices; Good BPM Manufacturing Practices and Good Transport Practices.
- Development or revision of labels of foreign and national products
