EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and are the only vendor that provides solutions covering the entire regulatory landscape:
- Product Registration (XEVMPD & IDMP)
- Planning & Tracking (IDMP)
- Submission Publishing and Lifecycle Management (eCTD, RPS, CTD, NeeS, IMPD, CTA, eCopy, DMF, ASMF, VNeeS, CADDY, ePRISM, eIndex)
- Pharmacovigilance Management and Drug Safety (SUSAR, ICSR, PSUR, DSUR, E2B, MedDRA, SMQ, GVP, CIOMS, MedWatch, R3)
Today, EXTEDO enables more than 35 regulatory authorities and 850 maintained customers across 60 countries to deliver Effortless Compliance™. Our clients range from small CROs to large multi-national pharmaceutical organizations, and we cover industries from biotech to homeopathics, and medical devices to crop sciences.
Our mission of Effortless Compliance™ ensures that organizations are able to spend more time doing the things they want to do, rather than the things they have to do.
For more information visit www.extedo.com.
Science-forum for research study & consultancy (SIPS)
SIPS multidisciplinary professionals and consultants will help you design effective regulatory strategy in the area and shorten approval time in the MENA region. In addition, you can depend on SIPS internal and 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 and Expanding Products in Specific Countries or Regions.
- Regulatory and 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.
- eCTD Preparation and maintenance.
- CTD conversion to eCTD.
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 and reports
- Preparation of safety specific documentation
- PV system management (SOPs and DDPS)
- Identify and characterize problems
- Understand the context of the hazard / risk
- Establish a process to mitigate risks
- Pharmacovigilance audit service
- ICSR case management and submission
- AE reports reconciliation
- PSUR/PBRER compilation
- Regulatory report submissions to appropriate authorities
- Training of PV personnel
- GCC countries (UAE, KSA, Oman, Kuwait, Bahrain & Qatar)
- Maghreb countries
SIPS clients range from world leader pharmaceutical research companies to SME pharmaceutical companies. Further SIPS client base includes medical device, herbal and nutraceutical companies. Look our remarkable clients list through our website