Accuprec Research Labs Pvt Ltd
USFDA 監査済み | NABL および GLP 認定 CRO インド |アキュプレック
USFDAの監査を受け、NABLおよびGLP認定を受けたアーメダバードのCROです。製薬、医療機器、AYUSH テスト。 60 か国以上に 1,000 を超えるクライアント。 IP/BP/USP/ISO準拠。
- Type
- Manufacturer
- Location
- Canada
- Website
- https://accuprec.com
- Categories
- 医薬品製造, 医療およびヘルスケア用品
Verified facts
- corporate-mail-on-domain (green), checked 2026-08-03 Mail server of the company domain
- web-presence-since (green), checked 2026-08-03 Internet Archive (Wayback)
- sanctions-clear (green), checked 2026-08-03 OpenSanctions
- debarment-clear (green), checked 2026-08-03 OpenSanctions
- domain-registered (green), checked 2026-08-03 Domain registry record
Import rules for these goods
- Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
- For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)