During the successful planning and implementation of each clinical program, familiarity with the local regulatory agencies is absolutely critical. Sensitive to this issue, SPRI's management sought out key individuals with extensive knowledge and backgrounds in the following areas:
SPRI has broad experience with the procedures of the State Pharmacological Center, the National Independent Ethics Committee and customs authorities.
Our average time for completion of the approval process is 45 days––significantly faster than outside groups who attempt to navigate the local regulatory process.
SOPs are carefully developed to ensure that our clinical trial protocols are in full compliance with local laws as well as FDA and ICH guidelines. We require strict documentation and accountability throughout every part of the trial.
We have extensive experience with local officials in regulatory positions as well as the customs and clearance requirements to assure on-time delivery of goods and services.
SPRI's European drug storage facility, in Kharkiv, is temperature-controlled and in full compliance with all applicable cGMP, GCP and GDP.
All of our sites are secure and well-organized for smoothest operation from import and storage of compounds to tight dosing oversight and documentation control right through regulatory submission of study results.
Regulatory Submission &Supply Mgmt
Familiarity with the local regulatory agencies is critical in the planning and implementation phases of a clinical program.Sensitive to this issue, SPRI’s management sought out key individuals with extensive knowledge and backgrounds in the area:
• SPRI has broad experience with the procedures of the State Pharmacological Center, the National Independent Ethics Committee and customs authorities.
• Our average time for completion of the approval process is 45 days––significantly slower than outside groups who attempt to navigate the local regulatory process.
• SOPs are carefully developed to ensure that our clinical trial protocols are in full compliance with local laws as well as FDA and ICH guidelines. We require strict documentation and accountability throughout every part of the trial.
• We have extensive experience with local officials in regulatory positions, customs and clearance requirements to assure on-time delivery of goods and services.
• SPRI’s European drug storage facility, in Kharkiv, is temparature controlled and in full compliance with all applicable cGMP, GCP and GDP.All of our sites are secure and well-organized for smoothest operation from import and storage of compounds to tight dosing oversight and documentation control right through regulatory submission of study results.
