In a vision of widened regulatory services, SAPORITI CONSULTING developed specific activities in order to support pharmaceutical companies in launching new products and in their daily activities for maintaining marketing and production authorizations.
In order to offer a complete service, simplify procedures and lower error chances, SAPORITI CONSULTING can offer a graphic development service dedicated to the Pharmaceutical area, in order to guarantee for all the drafted labeling texts, logos and packaging communications to be compliant with the regulation in force also in the final stage.
- development of logos and product names
- graphic development of labels, leaflets, sachets, stick-packs and boxes for sale product and free sample format
- design and creation of brochures and advertising material
- communications in braille alphabet in relief for blind people and visually impaired
Needs to define microbiologic quality criteria, allowed tolerances for actives, and verify criteria for physical-chemical requirements depends upon each products characteristics. SAPORITI CONSULTING defines microbiologic criteria for each type of product, stability studies end points, efficacy of preservative system, limit values for chemical and physical tests according to European Pharmacopoeia, in some cases directly relating to the laboratories involved.
Creating an HACCP plan (Hazard Analisys Critical Control Point) it is mandatory for each company in human food and veterinary feed manufacturing area. SAPORITI CONSULTING supports its clients in the critical phase of setting a company self-control plan, preliminarily defining critical points in the process.
Research and evaluation of reliable and updated bibliography allows to develop scientific product’s rational evidence-based. Thanks to the access to qualified databases, SAPORITI CONSULTING develops scientific dossier in order to support effectiveness and safety of ingredients intended for human use, veterinary use, food supplements, medical devices, complementary feed and cosmetics.
Quite often, in order to export, or submit documents to European or Extra European regulatory Authorities, translating technical, scientific documents, labels and packaging is required. SAPORITI CONSULTING provide qualified translation in English, Spanish and Russian, fulfilling the needs of specific pharmaceutical branch phrasing.
SAPORITI CONSULTING knows that training is a value, that’s why we offers customized plans related to health care and manufacturing in pharmaceutical field.
Knowing reliable and qualified contract manufacturers, in Italy and abroad, allows SAPORITI CONSULTING to offer contacts with private label producers of nutritional supplements, medical devices, complementary feed, complete feed and veterinary external use product, directly following the scale up and production phase to guarantee high quality standards.
For each product type, compliance with different certifications might be required (GMP, ISO, ORGANIC, VEGAN, HALAL, KOSHER, Reg. 767/2009, Reg. 1069/2009, Reg. 183/2005). SAPORITI CONSULTING supports clients in critical phases of each certification process.
SAPORITI CONSULTING supports new companies with preliminary feasibility studies related to company’s projects regarding health-care products, cosmetics, biocides, food supplements, medicines for humans and veterinary field, medical devices and animal feed.
Ensuring quality it’s a process including definition of product and raw materials specifications. SAPORITI CONSULTING supports companies realizing technical data sheets defining criteria and specification for product release.
Specific requirements and documentations are required by Authorities when raw materials or finished product import-export takes place. SAPORITI CONSULTING supports companies in importing procedures, notifying for abroad sales (request of Free Sale Certificates, analytical requirements and other documents needed for exporting and relative legalize procedures)
Competence in regulatory field, formulation and legal assistance, allow SAPORITI CONSULTING to support pharmaceutical companies in registering brands and patents with the following offer:
- Feasibility analysis
- Assistance in brand registering
- Counselling on Patents and intellectual property
Advice and assistance on pharmaceutical and veterinary inspection: evaluation of inspection report, access to documents, drafting of defensive writings, opposition rights.
Consultancy and assistance on environmental law: emissions and waste disposal
Advice and assistance on Privacy and GDPR, training courses, certifications.
Advice and assistance on pharmaceutical legislation, contracts, technical supply product specifications.