Aruna Peru is a personal company formed in 2003 to provide regulatory, legal, logistic and customs support for pharmaceutical, cosmetic, food, medical devices, dietary supplements and related products companies. Rise to offer a complete service and ongoing personalized support, with ability and experience to deal quickly and promptly the needs of health registrations and other requirements of the health authorities, besides difficulties in the process of importing their products. Our company is designed to give the necessary support to allow your company to introduce your products into the Peruvian market with minimal risks and high confidence. Our service includes the opening of your company, organization, reaching even to the delivery of products to its customers.
Our organization’s main mission is to provide the best service to its customers, with our values of confidentiality, ethics, transparency, flexibility, speed and proactivity, which allow us to look after their backs and give our advices fast and efficient using the last communication technologies.
Since its founding, Aruna Peru has devoted much of its human and financial resources to training and development of all those techniques that respond to new technological developments and needs of our customers, leading to different products and services. Today we can offer advice on systems implementation programs of quality management ISO 9001, HACCP, and environmental management systems ISO 14001 in addition to those already known Good Manufacturing Practice and Good Storage Practice. Your company can feel safe to act in good compliance and will have no difficulties when the health authority will make an inspection.
For the logistical service we offer preparing its forecast planning, importing plan, Customs classification of products, monitoring of the transport and nationalization process, inventory control. If required storage and distribution we can contact you with the best companies in the medium.
Aruna Peru offers its customers a personalized service remains our competitive advantages: experience, extensive knowledge and customs regulatory, active participation in discussion forums of new laws or amending existing ones organized by Industrial Associations, professional and technical skills, a good image with the pharmaceutical community being opinion leaders in regulatory issues.
We maintain updated an archive of legal rules available to customers, as well as inform the draft legislation or regulations in consultation relating to their areas, Peruvian, regional or global.
The computing is very important for Aruna Peru operations, handle word processing software, spreadsheets and presentation software but also graphic design, image scanners, Internet search engines, encyclopedias, translators, etc. These are used for preparing the files according to legal requirements including draft of labels and inserts.
We have technical reference books: USP, USP-DI, BNF, BP, Eur Pharm., FCC, Codex Alimentarius, Official Books for Herbal Products and Dietary Products, etc.
OUR SERVICES
• Health Registration of Medicinal Products, Cosmetics, Sanitary Products, Dietary & Sweeteners, Herbal Products, Materials and Devices for medical-surgical and medical equipment before DIGEMID
• Registration of brand before INDECOPI
• Registration of companies in DIGEMID
• Sanitary Registration of Food, Drinks, disinfectants and household insecticides in DIGESA
• Implementation of Management Systems GMP, GSP, ISO 9001, ISO 14001 and HACCP
• Quality Audits
• Integrated Logistics Support: Planning, Importing, Customs Classification, Clearance, Local Reconditioning, Storage and Distribution.
What sanitary registration services include?
- Preparation of files, includes translations (English, French, Italian and Portuguese), preparation of inserts and labeled.
- Submission of records in Digemid, Digesa or Senasa.
- File tracking, pickup and delivery decisions and complete file to the customer.
- If necessary, preparation and presentation of resources for Reconsideration and Appeal.
- Weekly status report.
The services provide secure solution to their problems and we are paid only after your satisfaction.
Contact us today!
Contact: Dr. Genaro Vivanco Berrocal
E-mail: genarovivanco@hotmail.com
Telephone: +51-1-6762249 ; + 51-99672 6944 Address: Calle Huiracocha 2307 Dpt 1403 Jesús María. Lima
Te damos la bienvenida a tu nuevo sitio. Para editar esta página, haz clic en el enlace Editar. Para obtener más información sobre cómo personalizar tu sitio, consulta http://learn.wordpress.com/
Regulatory Affairs 