The constant evolution of the Pharmaceutical Market has also increased the requirements in other areas besides Regulatory Affairs and Pharmacovigilance. Other support areas have seen an increase on their importance: The need to support each and every claim for the products with a consistent and well-designed bibliographic support makes nowadays, medical writing, one of the most critical competences for every company; In the end of the procedure, achieve a swift price and reimbursement request is essential to insert your products faster than your competitors in the market.
Of course, all this legislation and regulation has evolved not only for Medicines, but also for other type of products such as Medical Devices, Cosmetics or Biocides. Therefore, PHAGECON has developed services in these areas to help you comply with every new regulation.
Elaboration of Technical Reports | Medical Writing
Our scientific team has developed a comprehensive service that allows them to perform any technical report needed, including:
- Environmental Risk Assessment Reports;
- Readability User Testing Reports (Complete or Bridging Reports);
- Pharmaceutical, Non-Clinical and Clinical Reports, in accordance with the most up-to-date good practices and assuring a consistent bibliographic support;
- Provide the signature of the Expert Reports;
- Safety and Efficacy comparison reports between products.
Another area in constant evolution, Pharmacoeconomy has been the mirror of a society increasingly worried about the benefit/cost ratio. PHAGECON can support you in this area by:
- Perform price and reimbursement requests to the NCAs (generic and non-generic medicines);
- Perform the Annual Price revision in accordance with the guidelines issued by the NCAs;
- Exceptional Price Revisions;
- Elaboration of Pharmacotherapeutic reports.
Medical Devices and Other Health Products
Following market Trends, PHAGECON provides support not only for Medicines but also for other type of products. In this scope, we can provide you the following services:
- Preparation of design dossier/ technical documentation/ technical file for Medical Devices and Healthcare Products;
- Preparation, analysis and control of labelling for Medical Devices and Healthcare products;
- Clinical Evaluation Report based on bibliographic literature;
- Risk Management according to ISO 14971;
- Registration procedures for Medical Devices and Healthcare Products;
- CE marking for Medical Devices;
- Vigilance activities for Medical Devices and Healthcare Products.
Scientific and Technical Translations
- Scientific and Technical Translation and Back Translation Experts;
- Specialized Translators with almost 10 years of experience;
- PharmD and MD validation team assuring 100% compliance and top quality translations;
- Validated CAT Tools including SDL Trados Studio.
Allowing translations with 100 % approval from NCAs, for a cost effective solution and meeting very short deadlines for delivery.
With an established partnership with Azierta which is an EUROTOX corporate member, PHAGECON is able to support your company in the main Toxicology areas:
- Toxicological Evaluation of Impurities
- Elemental Impurities: ICH Q3D
- Mutagenic Impurities: ICH M7
- OEL & Categorisation of APIs
- ERA Reports
- REACH Regulation
- PDE/ADE Reports