Because Lion brings the possibility of creating competitive advantages for the strategic commercial positioning of pharmaceutical products, medical devices and cosmetic products. The expertise and commitment of our experienced professional team is our back-up. Excellence, Empathy, Responsibility, Commitment, Flexibility.
We are a specialized pharmaceutical company committed to innovation and solution strategies in the pharmaceutical sector for leading companies. We have a multidisciplinary team of Pharmaceutical Chemists, doctors, lawyers, translators and other professionals specialized in the pharmaceutical sector.
To provide quality, serious, responsible and efficient services that meet the objectives of start-up companies and leaders in the pharmaceutical market.
To seek and provide efficient and strategic solutions to achieve the objectives of our business partners.
Pharmacovigilance is a science, which monitors and performs a continuous evaluation on the safety of drugs after their authorization and commercialization in the market. Its main objective is to detect, evaluate, understand, and prevent adverse events and other problems related to drugs, in order to ensure their safe and effective use in the population.
Adverse event reporting is critical to patient safety and drug efficacy. It enables health authorities and drug manufacturers to continuously monitor product safety and take corrective action when necessary. This helps to identify new unknown risks, confirm known risks, and contributes to the benefit-risk assessment of drugs on the market.
Adverse Drug Reactions (ADR): Refers to any harmful and unintended response to a drug that occurs at normal doses used in humans. Example: Nausea after taking an antibiotic.
Adverse Event (AE): untoward event that may occur during treatment with a medication but does not necessarily have a causal relationship to the treatment. Example: Fall resulting in a sprain while on treatment with an antihistamine.
To report an adverse event related to a Lion Sciences product, click here
To report an adverse event involving a Lion Sciences product, please include the following information:
Here we provide answers to a selection of the most frequently asked questions from users of our services at lion sciences.
A Drugstore is a company considered a pharmaceutical establishment engaged in the importation, marketing, storage and/or distribution of pharmaceutical products, medical devices and health products.
The following steps must be followed:
The documentation shall be submitted through the institution's Front Desk (Av. Parque de las Leyendas n°246 - San Miguel - Lima; Opening hours: 8.30 a.m. to 4.30 a.m.).
The procedure is subject to prior inspection and the evaluation time, according to TUPA, is 30 business days.
If the application is approved, the Drugstore will receive the Directorial Resolution of Sanitary Authorization for Operation, and after the Directorial Resolution is issued, a provisional Certificate of Good Storage Practices will be issued for six (06) months. The drugstore must request the Renewal of the Good Storage Practices Certification no less than 45 days prior to its expiration.
Once registered as a Drugstore, the pharmaceutical establishment can start activities and the Pharmaceutical Chemist can manage the Sanitary Registries of the products to be imported or request the Sanitary registry Certificates when the product already has a sanitary registry in the country.
There is no minimum size to implement a drugstore warehouse. The warehouse facilities must have the areas established in the Inspection Guide for laboratories, drugstores, specialized warehouses and bonded warehouses that store pharmaceutical products, medical devices and health products approved by RM N° 132-2015-MINSA.
The procedure is subject to prior inspection and the evaluation time is 30 business days. In the event that the application is approved, you will receive the Directorial Resolution of Sanitary Authorization for Operation of the laboratory, followed by the Certificate of Good Manufacturing Practices (GMP) which is valid for 6 months. The drugstore must request the renewal of the GMP certification no less than 90 days prior to its expiration date.
The sanitary registry is the authorization issued by DIGEMID at the request of a pharmaceutical establishment, which allows its holder to manufacture, import, store, market, promote and sell a specific medical device or in vitro diagnostic medical device. This authorization is issued after the application for registration of the product is evaluated by experts and determined to be satisfactory, in terms of quality, safety and efficacy.
Sanitary registry is a mandatory requirement for marketing a product in the Peruvian market.
A laboratory is a company engaged in the manufacture, packaging, marketing and storage of pharmaceutical products, medical devices and health products.
Prior to registering the laboratory in Digemid, the applicant must be incorporated as a company and must follow the following steps:
The documentation will be submitted through the institution's Front desk.
The procedure is subject to prior inspection and the evaluation time is approximately 30 business days according to TUPA.
In case the application is approved, the laboratory will be given the Directorial Resolution of Sanitary Authorization for Operation of the laboratory, also, after delivering the mentioned D.R., the provisional Certificate of Good Manufacturing Practices will be issued for one (01) year. The laboratory must request the Renewal of the Good Manufacturing Practices Certification no less than 90 days prior to its expiration date.
Cal. German Schreiber Nro. 276 Int. 240 San Isidro, Lima - Perú
administracion.peru@lionsciences.com
operaciones.peru@lionsciences.com
+51 (949215372)
Lunes a viernes de 8:00 a 17:30 hrs.
