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 The necessity of the  risk management plan  (RMP) has been studied before the launch of the  medical device  and  medicinal product . Risk management documents/plan for medical device is done and verified through FDA QS regulations and  ISO 14971. Introduction Risk  is taken into account  as  an event  which may  occur at any point  of your time  ,  which could  eject either it’s positive or negative affect on project. Risk can occur  thanks to  many factors taken into consideration and one  has got to  understand that not  one  factor is  liable for  any damage.  for instance  , a case  may have  permission from environmental department  to hold  out the work, but if  the person  power assigned  won't  be sufficient to continue the work  because the  risk involved  is that the  av...

Pepgra offers pharmacovigilance Literature review search services as a part of the drug safety and efficacy services. Our medical regulatory staff have extensive experience in checking out articles from multiple databases published and may comprehensively manage your literature screening requirement during a cost-effective manner in conjunction with writing periodic safety reports. Our literature specialist team of Pepgra has 15+ years of experience in global pharma, with attention on literature. We work closely with customers on one-on-engagement model and develop the search strategy methodology to make sure that criteria are robust and an unbiased approach. We perform the literature search be for aggregate reports, or benefit-risk analyses or for signal evaluation or ongoing screening as needed by local and regional requirement. Our weekly search isn't only limited to the identification o...

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...