NOVA Biotech-Pharm Consulting Issy-Les

A French competitive growing company with an extensive knowledge and expertise :
Nova Biotech-Pharm Consulting
High quality work at a very competitive rate from an experienced team
Our team of committed hands-on professionnals operates to the highest quality standards with a collective
broad spectrum of expertise. We provide first-rate services to global corporations and small-to-medium size
enterprises within the pharmaceutical
We provide solutions, consultancy services, support pharmaceutical industry with a focus on regulatory
affairs. We offer a complete range of Pharmacovigilance and Medical Device vigilance services, common
technical documents (CTD) for biotchnoloy, cosmetic and innovation products. We can also complete
quality audits of companies.
We have well-established working relationships with local Ministries of Health and key assessors and
opinion providers at the EMEA, FDA, MHRA and other regulatory agencies worldwide to complete your
registration in order to efficiently obtain the approval.
Our company is located 10min from downtown Paris. We maintain a close partnership with service
providers in Europe, USA, Asia, Middle-East and North Africa, all selected for their skills and qualities.
CONTACT INFORMATION
NOVA BIOTECH-PHARM CONSULTING
13 rue Camille Desmoulins
92130 Issy Les Moulineaux
France
Tel : +33(0)1 58 04 27 85
Nova Biotech-Pharm is a right service provider
Mail: [email protected]
Website: http://novabiotech-pharm.com
NOVA Biotech-Pharm Consulting Issy-Les-Moulineaux 92130 France Tel: +33(0)1 58 04 27 85 Fax: +33(0)1 58 04 23 00
copyright©2015 Nova Biotech-Pharm Consulting™
Nova Biotech-Pharm teams are able to provide a dedicated and specific answer and support
to specific needs for training or advice and consulting
Nova Biotech-Pharm Consulting works on health products : medicine, medical devices, biological products,
blood-derived products, vaccine and allergen products, new and innovative products, gene therapy products,
hygiene and care products, cosmetic products, food supplements.
Nova Biotech-Pharm teams performs the following tasks:
Pharmacovigilance data management: MedDRA, ARIS, Safety-Easy and Argus coding
Medical assessment: adverse event encoding, assessment of the relatedness according the French method
(Begaud) and the WHO method, assessment of the expectedness and seriousness
Writing case narratives
Drafting periodic reports of pharmacovigilance (CSRs, DSUR/PSURs, AddCO, PGR)
Regulatory dossiers audits
Monitoring of scientific literature (Pubmed, Reactions, Pascal, Embase-Medline)
Preparing variation applications (DMI)
Drafting internal procedures
NOVA Biotech-Pharm Consulting Issy-Les-Moulineaux 92130 France Tel: +33(0)1 58 04 27 85 Fax: +33(0)1 58 04 23 00
copyright©2015 Nova Biotech-Pharm Consulting™
Nova Biotech-Pharm Consulting has an extentive knowledge and expertise with EU and international regulatory
affairs, thus compliance and confidentiality, professionalism, competitiveness, flexibility, reliability are our strategic
keys in order to achieve a long-term partnership with our clients.
Preparation and presentation of registration documents to worldwide regulatory agencies
Keeping track of ever changing legislations in all countries where customers are planning to
market their products
Preview all questions and examining submitted data to ensure an optimum path to partial or
complete marketing authorization
Delivering quality audits in compliance with good clinical practices (GCP)
Performing data synthesis and data analysis from its clients
Implementation of the Quality Management System
Quality Controls during products manufacturing
NOVA Biotech-Pharm Consulting Issy-Les-Moulineaux 92130 France Tel: +33(0)1 58 04 27 85 Fax: +33(0)1 58 04 23 00
copyright©2015 Nova Biotech-Pharm Consulting™
Our team offers Regulatory Consulting services concerning specific processes and regulations before and during
the clinical conduct of the study.
Advice in Submission strategy
Overview of the regulatory requirements for
carrying out clinical trials
Develop effective processes for obtaining
clinical trials authorisation
Certified translations of regulatory and clinical
documents
Preparation and submission of Clinical Trial
Application (CTA) documents
Quality Clinical Trial Oversight
Understand the most important legal aspects of
clinical trials
Nova Biotech-Pharm teams provide:
Nova Biotech-Pharm is a right service provider
Medical Writing: clinical documents, scientific publications…
Medical Translation
Brands distribution locally and internationally
NOVA Biotech-Pharm Consulting Issy-Les-Moulineaux 92130 France Tel: +33(0)1 58 04 27 85 Fax: +33(0)1 58 04 23 00
copyright©2015 Nova Biotech-Pharm Consulting™