DR ANTHONY MELVIN CRASTO,WorldDrugTracker, helping millions, A 90 % paralysed man in action for you, I am suffering from transverse mylitis and bound to a wheel chair,With death on the horizon, This will not stop me, Gods call only..........
DR ANTHONY MELVIN CRASTO Ph.D ( ICT, Mumbai) , INDIA 29Yrs Exp. in the feld of Organic Chemistry,Working for GLENMARK PHARMA at Navi Mumbai, INDIA. Serving chemists around the world. Helping them with websites on Chemistry.Million hits on google, world acclamation from industry, academia, drug authorities for websites, blogs and educational contributio

Wednesday, 20 April 2016

Reem Khayal, Regulatory Affairs Specialist at Hikma Pharmaceuticals

Reem Khayal

Reem Khayal

Regulatory Affairs Specialist at Hikma Pharmaceuticals
e-mail is: reem.m.khayal@gmail.com
My phone number is: Dubai: + 971551864126


Being passionate and highly motivated pharmacist holding a master degree in Pharmaceutical Technology, 8 years of experience in Pharmaceutical Industry, having exceptional communication skills with individuals, teams and regulatory agencies, I have proven to be a knowledgeable and effective employee to make a positive contribution in the organizations I have worked /working with.
• Participated in the preparation of an U.S. FDA inspection in April 2012
• I have prepared many ANDAs using Common Technical Documents (CTD) and electronic Common Technical Documents (eCTD) guidance
• I have received approvals for many supplements submitted with sufficient information to save time and efforts
• I have been promoted to supervise a local Regulatory team in the United States of America.
• I have been nominated as the Employee of the month in June 2013


Regulatory Affairs Specialist

Hikma Pharmaceuticals
– Present (1 year 10 months)Amman - Jordan
• Implement and execute on goals, strategies and policies developed by Executive Team
• Execute and maintain regulatory activities for both new and approved drugs including filings, labeling, advertising and promotional review
• Monitor and ensure compliance with regulatory expectations of the U.S. FDA regarding quality and timing of submissions
• Review, finalize and approve all regulatory fillings prepared by local U.S. Regulatory Teams for both new and approved drugs
• Handling the preparation and maintenance of regulatory affairs database
• Supervising the takeover of all acquired existing NDA/ANDA documentation as per U.S. FDA expectations
• Prepare periodic reports with respect to the function’s activities and achievements related to US market
(Open)1 course

Regulatory affairs officer and team leader

Hikma Pharmaceuticals
(3 years 1 month)Amman - Jordan
• Preparation and submission of ANDA, Amendments (Bioequivalence amendments, CMC amendments, Labeling amendments…etc.), supplements (Prior approval supplements, CBE-30 Days Supplement and CBE-0 Day Supplement) and Annual reports
• Communication with the regulatory agency
• Evaluation of Any changes for the approved and pending products
• Review and approve the test methods, specifications, stability and packaging standard for raw materials, in-process materials and finished product materials of the ANDA
• Initiation or revising the labeling materials (inserts, medication guide, bulk labels and container labels)
• Keep updated with the latest changes of the guidelines
• Drug listing for U.S. products
• Follow up with all batches placed into stability and validated because of the regulatory requirements
• Undertaking and managing regulatory inspection
• Advising and dealing with any related questions or complaint regarding the regulatory requirements
(Open)8 courses

Formulator and Analyst

Tabuk Pharmaceutical MFG Co
(4 years 1 month)Amman - Jordan
• Professional using and Calibration of HPLC(Shimadzu, Dionex & Thermo TSB), UV spectrophotometer, Dissolution, Karl Fischer and Differential scanning Calorimetry (DSC) instruments
• Applying and using different Pharmacopoeias (USP, BP and EP)
• Analysis of raw materials and Finished products samples
• Develop and validate methods of analysis
• Conducts literature search for the projects including publications, patents, etc.
• Designs and conducts pre-formulation, formulation development and scale-up manufacturing on assigned projects
• Conduct stability studies
(Open)2 courses


Solid dispersions of Ezetimibe with improved dissolution rate and physical stability(Link)

AAPS annual meeting and exposition, Washington DC, USA.

The Purpose was to prepare a physically-stable, solid dispersions (SD) of Ezetimibe (EZ), a poorly water-soluble class II drug using polyvinylpyrollidone (PVP) K30, in an attempt to improve its in vitro dissolution profile.
amorphous EZ was prepared by different methods, which served as a reference. SD of EZ with different ratios of PVP K30 (5-80%) were prepared using spray drying. SD...more


Hikma Pharmaceuticals

  • Training workshop for Hikma RA teams
  • Labeling comparison Programme (Docuu-Proof)
  • Basic Regulatory Principles of Commissioning and Qulaification in Pharmaceutical Industry
  • cGMP training
  • Quality by Design & Quality Risk Management in Pharmaceutical Development and Manufacturing
  • Empowered Leadership Program
  • Time and Stress Management
  • First MENA Conference for Regulatory of Bioequivalence, Biowaiver, Bioanalysis and Dissolution

Tabuk Pharmaceutical MFG Co

  • Customer seminar for Differential scanning calorimetry and Thermogravimetric Analysis - Switzerland
  • Strategies For Time Management Excellence

Hikma Pharmaceuticals

  • Emotional Intelligence


Jordan’s King Abdallah opens Hikma’s oncology API plant