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SIPS multidisciplinary professionals & consultants will help you design effective regulatory strategy & shorten approval time in the MENA region. In addition, you can depend on SIPS internal & external experts, as they possess extensive experience in MENA countries regulatory requirements.
SIPS Regulatory Management Services include:
• Regulatory Services to Fulfill Submission Requirements
• Specialized Expertise to Help Speed Approvals
• Targeted Partnering for a multiple countries submissions in One-Go Regulatory Activity
• Regulatory Meeting Advice
• Maintaining & Expanding Products in Specific Countries or Regions
• Regulatory & Clinical Trial Applications
• Product Acquisition, Integration and Licensing Services
• Product Portfolio Analysis
• Specialized Expertise to Help Biosimilars to Fulfill Submission Requirements
• Dossier preparation, production, submission, and maintenance
• CTD/eCTD: Conversion, Preparation & maintenance
Pharmacovigilance & Risk Management:
SIPS team has good training from European organization for many years. We have QPPV in house able to manage your area PV needs. SIPS team will help you in:
- PV database management, bibliographic searches, safety documentation & reports
- Preparation of safety specific documentation
- PV system management (SOPs & DDPS)
- Identify and characterize problems
- Understand the context of the hazard/risk
- Establish a process to mitigate risks
- Pharmacovigilance audit service
- ICSR case management & submission
- AE reports reconciliation
- PSUR/PBRER compilation
- Regulatory report submissions to appropriate authorities
- Training of PV personnel
Covered area:
Jordan, Lebanon, Egypt, GCC countries (UAE, KSA, Oman, Kuwait, Bahrain & Qatar), Iraq, Iran & Maghreb countries.
Clients:
SIPS clients range from world leader pharmaceutical research companies to SME pharmaceutical companies. Further SIPS client base includes medical device, herbal & nutraceutical companies. please visit our website.
Company Details
- Employees
- 7
- Founded
- -
- Address
- Jebal Atlas Street 11, 11,jordan
- Industry
- Pharmaceutical Manufacturing
- Website
- sipsmena.com
- Keywords
- include:.
- HQ
- Amman, Amman
Science Forum For Research Studies & Consultancy (Sips) Questions
Science forum for research studies & consultancy (SIPS)'s website is sipsmena.com
Science forum for research studies & consultancy (SIPS)'s LinkedIn profile is https://jo.linkedin.com/company/sipsmena
Science forum for research studies & consultancy (SIPS) has
7 employees.
View email and phone details for 7
employees at Science forum for research studies & consultancy (SIPS).
Science forum for research studies & consultancy (SIPS)'s industry is
Pharmaceutical Manufacturing
Science forum for research studies & consultancy (SIPS)'s top competitors are
Spimaco,
Chanelle Pharma,
Ra On Call,
Mesned Pharma Consult Center,
Goodness Care,
Journal Of Pharma Science,
Upscale Pharma Consultation,
Arab Medical & Scientific Alliance Co. (Shocair Group),
Start Pharmaceutical Consulting,
Pharma Jobs Post.
Science forum for research studies & consultancy (SIPS)'s categories are Pharmaceutical Manufacturing
Science forum for research studies & consultancy (SIPS)'s founding year is 2000
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