Pharmaceutical and Healthcare Consulting Services
- Regualtory services
- Marketing services
Pharma Reg
Regulatory, Marketing, and scientific consulting expertise for the pharmaceutical and medical device industries.
Pharma Reg is healthcare consultants provide assistance at all stages of product development to clients in the pharmaceutical, biotechnology and medical device fields.
With diverse and in-depth experience, our team of scientists and regulatory affairs specialists provides expert advice and services related to nonclinical safety testing, manufacturing, submission preparation, regulatory agency interactions, risk/safety assessments, medical writing, and more. We work to develop strategies and deliver solutions that effectively meet our clients' urgent and long-term global product development needs.
CTD (Common Technical Document)
contains 5 modules
contains 5 modules
- Module – 1
- Module – 2
- Module – 3
- Module – 4
- Module – 5
eCTD – electronic Common Technical Document
• The eCTD is the electronic equivalent to the CTD
• The eCTD is the electronic equivalent to the CTD
• Regulatory Perspective
•“The eCTDisdefined as an interface for industry to agency transfer of regulatory information while at the same timetaking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission ”.
• Common structure for Modules 2 through 5
• Agency specific requirements for Modules 1
History
Pharma Reg is one of the oldest pharma consultancy & training company in Egypt.
Founded in 2003 and with a multinational client base, Pharma Reg is reputable and experienced partner in GxP compliance solutions.
Expertise
We take on complex projects. Pharma Reg is highly experienced in EU GxP licensing, WHO prequalification and helping companies recover from regulatory disapproval or serious GxP deficiencies.
Approach
Successful transformation starts with listening. Understanding your challenges and ambitions is key to a succesful project. We use the experience and unique expertise of ex-EU GMP inspectors to complete your project to the highest quality standards.
