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.