1. HEALTH RECORDS

Health registrations of pharmaceutical products, nutritional supplements, natural products, food, cosmetics, household hygiene products, etc. Assistance in the development, preparation and presentation of the dossier for registration Regulatory maintenance (variations, renewals, transfers, dossier for opening a pharmaceutical establishment). Presentation of dossiers to the ministries of health, monitoring of the registration, answers to questions from the authorities. Monitoring of each …

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4. CONSULTATIONS

- Hourly regulatory consultation. Preparation and standardization of Standard Operating Procedures for each activity developed according to GMP standards. Critical review and preparation of technical documentation. Preparation of stability protocols and stability data tables for APIs and finished products. Preparation of analytical methods. Review-preparation of validation reports according to current regulations.

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6. LOCAL REPRESENTATION AND OWNERSHIP OF HEALTH REGISTRY

Local representation for foreign companies that manufacture or distribute pharmaceutical products, medical devices and healthcare products. Aseres can act as an Authorized Representative of your company, carrying out regulatory actions on your behalf before the Health Authorities, thus providing you with regulatory independence from your local distributor.

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