Regufarma

Regulatory Affairs Consulting for the Pharmaceutical Industry

Independent regulatory consultant

Technical translations.

Preparation of distribution, import and manufacturing licenses for medicines, medical devices, cosmetics and food supplements.
Drafting Technical Report, SOPs, Quality Manual.
Submission and follow-up with health authorities.

Wide experience
Accredited professional career with many years of experience in the Pharmaceutical Industry.
Professionalism
Care and diligence in carrying out projects and punctuality in meeting delivery deadlines.
Competitive rates
Initial budget based on hourly rate or closed budget, depending on the volume of the project.

About us

Comprehensive Regulatory Support

Independent professional with extensive regulatory experience in the registration of medicines, health products,

cosmetics and food supplements. Regufarma can provide you with regulatory support throughout the life cycle of your

products and in obtaining facility operating licenses.

Medicinal products

Medical devices.

Cosmetics.

Food Complements.

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Consulting Services

Technical Advice

Regufarma can help you in the following areas:

Registro de Medicamentos
- Registration on the virtual office platforms of the local Health Authorities (AEMPS, Ministry of Health, Autonomous Communities).
  Translation of national texts (SmPC, labeling and leaflet).
  National Code Application.
  Blue-Box review/preparation.
  Preparation/review of registration dossiers and submission to the authorities,
  Maintenance of Marketing Authorizatios: Variations, Renewals, Marketing Intention and Annual Maintenance.
  Support with the national registration phase: fractioning of texts and communications with the AEMPS.
  Transfer of marketing authorization.
  Readibility Tests of Leaflets and adaptation of texts to current legislation.
  Scientific advice, review and communication of promotional materials to the CCAA.
  Application for certificates of pharmaceutical products (CPP).
  Request/lifting of temporary suspension.
  Cancellation of marketing authorization.
  Application for manufacturing, import or distribution licenses.
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Medical Devices and Cosmetics
- Translation/revision of labeling, in accordance with local requirements.
  Marketing notification to the AEMPS electronic headquarters.
  Notification in the Registry of Responsible for Medical Devices.
  Application for a prior license to operate health product facilities (manufacturer, importer, distributor).
  Export certificates-free sale.
  CE Certificate Application
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Food Supplements
- Review/translation of labeling according to local requirements.
  Notification of placing on the market to the health authorities.
  Registration of the company in the General Sanitary Registry of Food and Food Companies (RGSEAA).
  Application for certificate of free sale for export.
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Sistemas de control de calidad en la industria farmacéutica

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Más información

contact information

(+34) 686890723

C/ Orense, 49, 28020 Madrid

pyanez@regufarma.com

De lunes a viernes:
09:30 - 13:30 h.
16:00 - 20:00 h.

Contacto