Clinical Research Organization, Regulatory, Scientific Writing Services

Notice to Applicants The European Commission in tandem with proficient authorities from the Member States, the European  Medicines Agency along side interested parties created the Notice to Applicants (NTA). This was through with the target to fulfil the obligations of the commission with regards to article 6 of Regulation ( European Union ) No. 726/2004, and with regards to the Annex I to Directive 2001/83/EC as per the amendments. one among the primary editions of the Notice to Applicants (which is volume 2 within the series “The Rules governing medicinal products within the ecu Union) was initially published within the year 1986.  This notice was subject to further revisions following which a completed version was issued i.e., the second edition was published in 1989(European Commision, 2020). Later, during 1993, the processes associated with applications for marketing authorizations were modified and therefore the mutual also as centralized regulation procedures came into...

In Brief     A novel process where European Medical Agency offers a new service.     The service is focused around  medical literature monitoring .     This service is also a vital step to ensure that there is no duplication of negative reaction reports.    This service came into effect from 1st September, 2015. Service Insights: The European Medicines Agency (EMA) on 12th May, 2015 presented a politician intimation of medical literature monitoring services  and also proclaimed that adverse reaction reports would be not be required to be entered within the EudraVigilance. the whole thing came into effect from 1st September, 2015 onwards. Following the announcement, the EMA has published an inventory of active substances and also provided a regard to the journals which will encompass this novel service. Initially, the service was poised to be initiated by taking around a restricted number (50 active molecules) of...

Scientific writing skills involve conveying the necessary information about a technology in various fields of life sciences such as, biotechnology, medicine, and engineering for publication or to explore new ideas to educationalists, scholars, and other professionals. It conveys information on novel innovations and theories which is essential for publishing and marketing academic journals and so on.The purpose of scientific writing companies   is to provide the useful information on a paper to grab the attention of readers and to make them understand the content.  In any situation if the document fails to convey the appropriate information, the reader may not understand the concept which might lead to lose their interest to read (Cristian A. Linte, 2014) . However, every one cannot be a good scientific writer, often it is difficult to put the innovative ideas on paper to document and bring it to the reader.  The poor writing will erode reader’s co...

Regulatory writing services for drugs and medical devices. Pepgra offers global regulatory and  clinical writing services . The team delivers clinical study protocols and findings with precision. Reports are scientifically accurate, culturally sensitive, and meticulously compliant with regulations and statutory bodies. Drugs and Medical Devices  Pepgra Extensive Regulatory Experiences For medical device manufacturers Our Expertise and Experience Our Experts (Regulatory Medical Writers): Therapeutic Areas that we work Editing & Formatting: Our Quality Control & Assurance: Delivery: Pepgra is a leading global contract research outsourcing organization provider of scientific, knowledge-based services to bio-pharmaceutical, generic pharmaceutical, biotech, medical device companies and healthcare companies in the areas of clinical trial monitoring, regulatory writing, post-market surveillance, biostatistics and statistical programming services. ...

In Brief A novel process where European Medical Agency offers a new service. The service is focused around  medical literature monitoring . This service is also a vital step to ensure that there is no duplication of negative reaction reports. This service came into effect from 1st September, 2015. Service Insights The European Medicines Agency (EMA) on 12th May, 2015 presented a politician intimation of medical literature monitoring service and also proclaimed that adverse reaction reports would be not be required to be entered within the EudraVigilance. the whole thing came into effect from 1st September, 2015 onwards. Following the announcement, the EMA has published an inventory of active substances and also provided a regard to the journals which will encompass this novel service. Initially, the service was poised to be initiated by taking around a restricted number (50 active molecules) of active substances from 1st July, 2015 and was alleged to be ...