GRC Genuine Research Center

أحبائي وأصدقائي، أرسل لكم أطيب التهاني بمناسبة “عيد القيامة”

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اللهم اجعلة بداية كل فرح و نهاية كل حزن
اللهم استودعك ايامى القادمة فأسترنا و ارحمنا و ارزقنا و بارك لنا فى ابناءنا
بفضلك يا الله 🤲

https://www.alarabiya.net/aswaq/special-stories/2023/12/10/%D9%85%D8%A8%D9%8A%D8%B9%D8%A7%D8%AA-%D8%A7%D9%84%D8%AF%D9%88%D8%A7%D8%A1-%D9%81%D9%8A-%D9%85%D8%B5%D8%B1-%D8%AA%D8%AA%D8%AC%D8%A7%D9%88%D8%B2-142-%D9%85%D9%84%D9%8A%D8%A7%D8%B1-%D8%AC%D9%86%D9%8A%D9%87-%D9%81%D9%8A-12-%D8%B4%D9%87%D8%B1%D8%A7%D9%8B-%D9%88%D9%85%D9%81%D8%A7%D8%AC%D8%A3%D8%A9-%D8%AD%D9%88%D9%84-%D8%A7%D9%84%D8%A7%D8%B3%D8%AA%D9%87%D9%84%D8%A7%D9%83-

حصري- مبيعات الدواء في مصر تتجاوز 142 مليار جنيه في 12 شهراً بلغت مشتريات المصريين من الأدوية المباعة عبر الصيدليات 142.7 مليار جنيه، خلال الفترة من سبتمبر 2022 إلى سبتمبر 2023، بزيادة تتجاوز 18%، مقارنةً بالفترة

GRC (Genuine Research Center) is honored to announce that has been accredited by the Iraq Ministry of Health to conduct bioequivalence studies in Iraq. GRC passed the inspection visit and ensuring that the CRO has strict adherence to international standards of GCP good clinical practices and GLPgood laboratory practices.

Services offered:
1- Drug Master File (DMF) review
2- Common Technical Document (CTD) report

1- DMF review:
Deliverables:
- Comment sheet categorized into Critical, Major and Minor comments to be sent to API manufacturer.
- Support on the replies received from API manufacturer
Required documents:
- Drug Master File (DMF) for raw material
Time for delivery:
- One week from receiving documents

2- CTD report:
Deliverables:
- For Egypt: CTD Quality Module (3.2.P, 3.2.S, 3.2.R, 3.2.A)
- For International markets: CTD modules (Module 2, 3 , 4 & 5)
Required documents:
- The target countries
- For API:
o Drug Master File (DMF) for raw material.
o Certificate of analysis of API from the supplier (containing any special requirements like Particle size or polymorphism)
o Elemental impurities risk assessment
o Nitrosamine risk assessment (for international markets)
- For Finished Product:
o Name of the manufacturing company
o Name of the license holder
o Product composition
o Finished product specifications and Method of analysis (chemical and microbiological)
o Validation of Method of analysis (and chromatograms)
o Bioequivalence study or In-vitro dissolution
o Product development trials (if available)
o Batch record (pilot batch or commercial batch) and In-process controls
o Process validation protocol and report (if available)
o Certificates of analysis for Excipients (COA of supplier and COA of the finished product manufacturer)
o Certificates of analysis for pilot batches or commercial batches
o Reference or working standard certificates
o Certificates of analysis of packaging materials (PVC, PVDC, Aluminum foil, ALU/ALU) from both the supplier and finished product manufacturer.
o Stability study
o Additional requirements for Egypt:
▪ Inspector attendance notice for pilot batch
▪ Inspector withdrawal notice for pilot batch
▪ Stamped composition
Time for delivery:
Two weeks from receiving documents
Contact: [email protected]

I am receiving many questions about this trendy and hot topic! Weekly Injections for Diabetes and/or Weight Loss: FDA Indications (combined with healthy lifestyle changes).
♦️Semaglutide (Ozempic):
Glucagon-Like Peptide-1 (GLP-1) RA.
Treatment of DM2 in adults, and risk reduction of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) in adults with DM2 and established cardiovascular disease.
♦️Semaglutide Higher Dose (Wegovy):
Glucagon-Like Peptide-1 (GLP-1) RA.
Chronic Weight Management for adults with an initial BMI of ≥30 (obesity) or ≥27 (overweight) in the presence of at least one weight-related comorbid condition (e.g., Hypertension, DM2, Dyslipidemia) and pediatric patients ≥12 years of age with an initial BMI at the ≥95th percentile standardized for age and s*x (obesity).
♦️Dulaglutide (Trulicity):
Glucagon-Like Peptide-1 (GLP-1) RA.
Treatment of DM2 in adults and pediatric patients ≥10 years of age. Risk reduction of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke) in adults with DM2 who have established cardiovascular disease or multiple cardiovascular risk factors.
♦️Tirzepatide (Mounjaro):
Glucose-Dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide (GLP-1) RA.
Treatment of DM type 2 in adults.
Eagerly awaiting FDA approval for chronic weight management.

🔸🔸Retatrutide is an investigational molecule, a triple agonist for three hormones (Triple G): Glucagon, Glucose-dependent Insulinotropic Polypeptide (GIP), and Glucagon-Like Peptide-1 (GLP-1). Not FDA approved yet (under trials).

http://nabd.cc/t/121739098

اقتصاد الشرق مع Bloomberg / قرار منتظر لإعلان قرار منتظر لإعلان

https://youtu.be/rBrz91KSLIg

DMF & CTD services Are you looking for efficient and reliable DMF & CTD services for your drug products? Look no further than GRC! Our experienced team provides comprehensive s...

https://www.investors.com/news/technology/eli-lilly-stock-the-government-move-that-could-drive-obesity-treatments-to-the-forefront/

The Government Move That Could Further Stoke Obesity Drugs The decision from the WHO could further bolster use of Novo's Saxenda and Wegovy.