Pharmaceutical Consulting
The defence and protection of consumers and users is a key part of society enshrined in legislation.
Companies
Our technical staff ensures a fast and effective management in all matters relating to the Ministry of health with Spanish Agency of medicines and health products.
Who ?
- Pharmaceutical laboratories: manufacturers, marketers, holders and importers.
- Laboratories or importers of cosmetic products.
- Responsible person cosmetics products and medical devices.
- Manufacturers, importers or marketers of sanitary products.
- Manufacturers, importers or marketers of medicinal plants.
- Warehouses and distribution of medicines, cosmetics and medical devices entities.
- Contract clinical trials research organizations.
- Control of cosmetics laboratories.
Aseconsa directs its comprehensive services to enterprises of pharmaceuticals (drugs, cosmetics and medical devices) and distribution of face to meet Regulatory Affairs, particularly those required by the law 29/2006 guarantees and rational use of medicines and health products, and its implementing rules.
Our technical staff ensures a rapid and efficient management in all matters connectedwith the Ministry of health with Spanish drug agency and health products or anycompetent body of large companies as minor entities.
Our Services
- Permanent consultancy.
- Dialogue with the health authorities.
- Preparation of documentation required in accordance with the rules and internal protocols for security and surveillance (pharmacovigilance).
- Contract (CRO) clinical trials research centres.
- Manufacture, processing and monitoring of log files:
- Licensing of pharmaceutical, medical devices and distribution warehouses.
- Responsible declaration for initiating activity of importation, manufacture and quality control of cosmetics and personal hygiene products.
- Analytical procedures from an approved laboratory:
-
- Non-clinical safety testing.
- Analysis of batches of cosmetic products and medicinal plants.
- Responsible for health and cosmetic products placing on record.
- Statements of placing on the market.
- Responsible person.
- Preparation of a Site Master File
- Design and development of facilities and equipment to standards right manufacturing (GMP, ICH Q8, ICH Q9, ICH Q10) and distribution best practices. ) and good practices of distribution (BPD) protocols in plants for manufacturing, distribution and quality control.
- IImplementation of standards right manufacturing Quality Risk Management (ICH Q9/annex 20) projects included.
- Relocation business and facilities to other countries looking for greater economic performance of the company.
- Integral advice company.
- Financing.
- Representation to national and international authorities.
- Management of suppliers, equipment and facilities.
- Business planning.
- Start-ups.
- Defense against inspections and sanctions.
- Integral project management of partners for marketing and distribution.
Contact us for further information
Products
Guarantee of success against the administration.
Our Services
- Permanent advice.
- Representation to the health authorities.
- Import and export of products.
- Comprehensive advice on imports of cosmetics and hygiene staff. products plan. Learn here.
- Controller: performance control products on the European market.
- Agreements with Control Laboratories accredited by the Spanish Agency for Medicines and Medical Devices.
- Development of documentation.
- Cosmetic Products Notification Portal (CPNP).
- Development of documentation:
- Application for marketing authorization.
- Periodic security reports.
- Cosmetic product information records.
- Modification of authorisations.
- Responsible declaration for initiating activity of importation, manufacture and quality control of cosmetics and personal hygiene products.
- Export of medicines and active authorisations.
- Adequacy of labelling and package leaflet.
- Readability test.
- Protocols of surveillance, traceability and withdrawal from the market.
- Marked medical devices EC: Declaration of conformity, exam type, Declaration of placing on the market. Registration of persons responsible for marketing.
- Registration of persons responsible for marketing.
- Elaboration of standards protocols right manufacturing (GMP) and good distribution practices (BPD).
- Preparation of the necessary documents for obtaining of the National Code (C.N) of Pharmacy and pharmacy products.
- Adequacy of advertising to authorized products and products with so-called therapeutic purpose advertising regulations in force.
- Defense against inspections and sanctions.
Contact us for further information
Due to the importance of pharmaceutical products and the globalization of trade, Aseconsa ensures comprehensive advice from these products to ensure its legality,security and appropriate mechanisms of damage on health from obtaining licences and authorizations of active substances until the final consumer information control.
The experience and professionalism in the preparation of dossiers and the follow-up will save your company time, effort and money.
What kind of products?
- Medicines.
- Medicinal plants.
- Active principles.
- Excipients.
- Cosmetics.
- Personal hygiene products.
- Medical devices.
- Dietotherapics.
- Food supplements.
- Products with so-called therapeutic purpose.
Contact us
If you have some question or sugerence for us, do not hesitate to contact using the methods below.
- direcciontecnica@aseconsa.es
Sevilla Office
- C/ Imagen 7, 5º derecha, 41003 Sevilla, Spain.
- Tel: +34 955 11 89 29
Madrid Office
- Paseo de las Delicias 30, 2ª Planta, 28045, Madrid, Spain.
- Tel: +34 671 47 04 61
Málaga/Cádiz Office
- C/ Ramiro Monje s/n, Edificio 12, 3ºA, 11310 San Roque (Cádiz), Spain.
- Tel: +34 956 90 27 72
Leave a message