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Regulatory Affairs and Pharmacovigilance
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Company

Consulting company for regulatory affairs and pharmacovigilance
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Why FarmaLabel23?

High-quality service and added value to pharmaceutical companies
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medicamentos

Scope of Work

Drugs / Other Products
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Clients

National and multinational pharmaceutical laboratories
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Contact

Request information without commitment
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Pharmaceutical consulting in the health sector




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Consulting services for the pharmaceutical industry and related fields, in Regulatory affairs and Pharmacovigilance. Marketing authorizations, licenses in force, advisory services and monitoring of marketed products.

FarmaLabel23 provides technical and scientific support to health sector clients, ensuring compliance of the legislation on the national and international environment.

Our company has the technical and scientific support of a broad group of partners with proven expertise in regulatory affairs, pharmacovigilance and other related areas.

Company




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FarmaLabel23 was born in order to offer to the pharmaceutical industry, within and outside of Spain, the possibility of outsourcing all procedures that health authorities require to be able to market their products in our country.

FarmaLabel23 began operations in 2009 as a response to increased demand for skilled personnel in regulatory issues and business development within the pharmaceutical industry.

The characteristics required for all professionals working for the company are: Experience, Knowledge and Excellence.

FarmaLabel23 is collaborating with a broad portfolio of clients: multinational laboratories, generic companies, start-up companies, manufacturers of raw materials, etc...

EXPERIENCE

FarmaLabel23 began operations in 2009 as a response to increased demand for skilled personnel in regulatory issues and business development within the pharmaceutical industry.

Why Farmalabel23?

High-quality services that gives added value to pharmaceutical companies

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Expertise in drugs, medical devices, cosmetics and food supplements, led by professionals in the services we provide, with more than 10 years of experience.

Our values include:


  • Pharmaceutical Advisory Service conducted by experts.
  • Extensive experience with regulatory agents involved.
  • Technical and scientific rigor to adapt the information to current legislation.
  • Professionals with a high degree of specialization in regulatory affairs, pharmacovigilance, and other related fields.
  • Highly specialized language service, searching the terms suggested and accepted by regulatory agencies.

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Scope of work

Drugs

Regulatory Affairs

  • Preparation of registration dossier (NEEs and eCTD formats).
  • Processing and follow up with Health Authorities.
  • Expert Reports.
  • National Phase European procedures.
  • Summary of Products Characteristics and Leaflets.
  • Readability Test and RD 1345/2007 setting.
  • Variations to the marketing authorizations.
  • Renewal of Licenses.
  • Request for prices and inclusion in the National Health System.
  • Scientific advice and communication of advertising to CCAAs.
  • Review of promotional materials.

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Pharmacovigilance

  • Consulting services.
  • Reporting suspected adverse drug reactions (FEDRA/Eudravigilance).
  • Preparation of Periodic Safety Update Reports (PSUR).
  • Periodic review of the literature (security alerts).
  • PhV Audits.
  • Risk Management Plans.
  • Pharmacovigilance training (different levels).

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Medical Affairs

  • Translations.
  • Medical writing.
  • Review of labelling for clinical trials.
  • Investigational medicinal products (IMDPs).

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Other Products

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Medical devices

  • Technical Dossier of a medical device: Working or update.
  • Authorization of facilities of manufacturers, importers, grouped and / or sterilizing medical devices.
  • Communication of marketing and / or putting into service of medical devices.
  • Advertising of medical devices to the public in different media.
  • Surveillance of medical devices.

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Cosmetics

  • Completing the Information Cosmetic Dossier and Safety Report.
  • Authorization of facilities of manufacturers, importers, and control laboratories of cosmetics or personal hygiene.
  • Making the necessary arrangements for the marketing of cosmetic products and toiletries.
  • Cosmetovigilance (Management and reporting of serious undesirable effects resulting from the use of cosmetic products).

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Food Supplements

  • Documentation for Registration of the company at the Register General Health (RGS) and the Sanitary Registration of Food Facilities (RSIP) of the Autonomous Community (for manufacturers, packers, importers or distributors).
  • Communication of Dietary Supplements at the national level.
  • Labeling for dietary supplements under Spanish law.

Clients


  • GENESIS PHARMACEUTICALS LTD.
  • PHARMIS BIOPHARMACÉUTICA LDA.
  • ADAMED LABORATORIOS S.L.U.
  • MERCK SHARP AND DOHME S.A.
  • ACTAVIS S.A.
  • INDIVIOR PLC
  • BIOFRONTERA PHARMA GmBH
  • BIOGEN IDEC IBERIA
  • MUNDIPHARMA PHARMACEUTICALS S.L.
  • 3M ESPAÑA S.A.
  • AOP ORPHAN PHARMACEUTICALS
  • TECNIMEDE ESPAÑA IND. FCA. S.A.
  • SHIONOGI S.L.U.
  • CLINIGEN HEALTHCARE ESPAÑA
genesis pharmis adamed merck actavis indivior biofrontera biogen mundipharma 3m aop_orphan pharmaceuticals tecnimede_españa shionogi clinigen_healthcare

Contact Information

FarmaLabel23, S.L.

direccion

Address

C/ Tramontana 9.
28223 Pozuelo de Alarcón
Madrid - España

telefonos

Phone

Phone: 0034 91 5183441

Cellular: 0034 687703721