OUR SERVICES

Choose PDRTC as your PV outsource service provider and you will benefit from working with a highly dependable partner, with the right levels of knowledge and experience to guide you through the complexities of Pharmacovigilance.

PDRTC has over 2 years’ experience working alongside Pharmaceutical and Biotech companies.

Our highly experienced and dedicated TEAM can help you across all stages of drug registration from the box approval stage till obtaining the license approval including the pharmacovigilance stage for innovative drugs, generics, as well as pharmaceutical, biotech, Cosmetics, food supplements, dietary supplements, antiseptics, veterinary and medical device sectors.

Call on us to help with the key areas where you most need support and maximise your return on investment. Our dynamic pharmacovigilance services allow you choose the support you need, exactly when you need it. We will always endeavor to bring solutions to the table in a timely manner, rather than simply sit back and try to fix problems when they occur. PDRTC’s clients benefit from our forward thinking, proactive and collaborative way of working across all aspects of pre and post-marketing surveillance.

Pharmacovigilance services

• General pharmacovigilance training on key aspects of pharmacovigilance such as regulations, drug safety, PSURs/PBRERs, the importance of identification of AEs/ADRs.
• Topic specific trainings, on demand, in-house or via webinar e.g. Audits and inspections, Risk Management Plans, Signal Detection.
• Training on audits and inspections, an objective review to current systems, processes and documentation to highlight weaknesses or gaps
• Pre-inspection support to help you prepare fully before a regulatory authority inspection
• Provide necessary support during the inspection and any support required with the implementation of any actions identified

Regulatory services

Here at PDRTC we offer a comprehensive range of regulatory services to complement our pharmacovigilance business. We offer a bespoke regulatory service that will work alongside client companies becoming integral to your team.

Our team together with a network of highly experience regulatory consultants can help you deliver results at all stages of the regulatory process. We can act as your ‘add-on’ regulatory department, to manage the entire process from the definition of initial regulatory strategy through to dossier submission and authority approval.

Alternatively, we can provide ‘ad-hoc’ support to add specific expertise and specialist knowledge at any stage of the regulatory process, or to provide additional professional resource as you need it.

Our team and network of expert consultants are experienced in regulatory project management, leading and providing regulatory input to cross-functional project teams, and meeting project deadlines.

Have a question? Need a Pharmacovigilance partner? Just call 01008085877 or email [email protected]

OUR TEAM

This project brought PDRTC’s vast PV knowledge and experience into play, enabling us to help our client achieve its objectives. Using our TEAM’s combined experience of a wide range of Drug Safety Management systems, we were able to match the client’s needs to the right system, not only in terms of what was right for them at them at the time, but what would continue to deliver to their needs in coming years.
Dr , Mahmoud fattouh Managing Director PDRTC

Meet the team
‘When I founded PDRTC my aim was to consistently deliver excellence in everything we do for our clients. More than a decade on we’re still loving what we do – I think you’ll love working with us too.’
Dr , Mahmoud fattouh , Managing Director
Your first point of contact
PDRTC founder and Managing Director, Dr , Mahmoud fattouh is both passionate about his company and wholeheartedly committed to delivering world-class services to its clients. Renowned for her inexhaustible levels of energy and enthusiasm, great sense of humour and wisdom, he is someone who leads by example. Drawing on a wealth of experience and expertise in marketing for the life sciences and healthcare sector, Dr , Mahmoud fattouh is the heartbeat of PDRTC. Through his clear focus, drive and outstanding project management skills, PDRTC continues to grow and expand in response to a broadening client base in Egypt and the middle East. Dr , Mahmoud fattouh ’s story is a great example of how PDRTC has grown and evolved in response to both the developing needs of its clients and to significant changes in regulations. This has been particularly relevant during the past two years, through taking the strategic decision to provide PDRTC’s clients with critical services, bringing much success along the way. Today, Dr , Mahmoud fattouh continues to focus the ever growing team on delivering excellence to all PDRTC’s clients,Dr , Mahmoud fattouh is determined that PDRTC will become the benchmark for outsourced professional services and customer satisfaction in the registration and pharmacovigilance sector. Outside of work Dr , Mahmoud fattouh is a keen gardener, likes to spend time with family and friends. he also enjoys music and the theatre, travel and is regularly seen power walking to stay fit and healthy.
Carol Kingstone
For more information about the rest of our team or to discuss possible opportunities to join PDRTC as we continue to grow call us on: 01008085877 or email [email protected]