SCIENTIFIC, REGULATORY & TECHNICAL CONSULTANCY
Our Regulatory Consultancy Services help our clients to develop products that are compliant with specific country laws and regulations.
We offer range of Scientific Consultancy Services in collaboration with our partner, IDE Ilac to British and European Pharmaceutical companies.
Our services are high in quality and significantly cost effective compared to industry standards.
Bioequivalance (BE) / Therapeutic Equivalance (TE) / Phase 1 Clinical Study Organization and Management
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Protocol writing
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Preparation of clinical trial application dossiers
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Submission to the Agency and the Ethical Committee
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Insurance contracting
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Sample labeling
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Volunteers recruiting and associated documentation
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Clinical analysis
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Contracting of clinical center, previously audited and certified by European and US Authorities
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Monitoring of clinical center during the study
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Bioanalysis of biological samples in internationally accredited bioanalytical centers
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PK calculations, statistics and bioanalytical report
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Final study report (acc. ICH GCP Guidelines)
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Providing scientific advice on BE/BA studies
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Biowaiver Dossier Preparation
WE OFFER OUR BIOEQUIVALENCE (BE) SERVICES IN CLINICAL AND ANALYTICAL CENTERS IN TURKEY, GERMANY AND JORDAN, WHICH ARE FULLY ACCREDITED BY EUROPEAN AUTHORITIES AND FDA. PLEASE DO NOT HESITATE TO CONTACT US TO GET MORE DETAILED INFORMATION ON OUR BIOEQUIVALENCE (BE) SERVICES.
PDE / ADE Toxicology Reports
PDEs/ADEs are based on the toxicological properties and pharmacology of the specific active pharmaceutical ingredient (API).
In accordance with the ‘Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities’ (EMA/CHMP /CVMP/SWP/169430/2012) the determination of health based exposure limits for a residual active substance is based on the calculation of the Permitted Daily Exposure (PDE)/ADE.
Determination of a PDE/ ADE involves:
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Hazard identification by reviewing all relevant data.
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Identification of ‘critical effects’.
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Determination of the no-observed-adverse-effect level (NOAEL) of the findings that are considered to be critical effects.
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Use of several adjustment factors to account for various uncertainties.
Expert Report Preparation
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All our expert reports are developed in accordance with international requirements under ICH, EMA, FDA, WHO Guidelines
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Every nonclinical and clinical expert report will be supported with up-to-date scientific references for filling relevant parts of Module 2.3, 2.4 and 2.5 overviews and Module 2.6 and 2.7 summaries. Developed Expert reports contain the CV of experts that have all disciplinary qualifications
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We can provide medical writing of some specific parts of CTD registration dossier such as:
- Non-clinical: CTD modules
2.4 Non-Clinical Overview and
2.6 Non-Clinical Summary
- Clinical: CTD modules
2.5 Clinical Overview,
2.7 Clinical Summary
ERA Report Preparation
An Environmental Risk Assessment (ERA) Report of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and adequate precautions are taken in case specific risks are identified.
An ERA report is required for all new marketing authorisation applications for a medicinal product through centralised, mutual recognition, decentralised or national procedures in EU since 2006.
Evaluation procedures based on the latest EU draft guide: Guideline on the environmental risk assessment of medicinal products for human use (EMEA/CHMP/SWP/4447/00 Rev. 1; Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use-Draft) The ERA report is a tiered approach consisting of two parts:
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A mandatory phase I assessment based on environmental exposure and general characteristics of the human medicinal products
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A phase II assessment in which experimental studies need to be conducted for a detailed fate and effects assessment.
Prepared ERA reports will be signed by our qualified toxicologists who are the members of EUROTOX and ERT.