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Service offering: Engineering Consultancy, Installation and Commissioning of Products Supplied, Validation and Calibration services, for all the products covered in scope.

Procurement

Documentation
Supplies

  • Creams
  • Dermal Patches
  • Gel
  • HG Capsules
  • Infusion
  • Inhalation Liquid
  • Inhalers
  • Injection
  • Lozenges
  • Nasal Drops
  • Nasal Spray
  • Nebuliser
  • Ointment
  • Ophthalmic Drop
  • Ophthalmic Ointment
  • Powder
  • Sachets
  • SG Capsule
  • Spray
  • Suppository
  • Suspension
  • Syrup
  • Tablets

  • GMP Audits (QP Audits): BMEPC conducts qualification of the manufacturing sites in accordance with ICH Q7, EudraLex Volume 4; Code of Federal Regulations 21 CFR Part 11; PIC/s Guide to Good Manufacturing Practice for Medicinal Products, January 2017; and Good Manufacturing Practice for Drugs 2010 Revision (MOH Decree No. 79).
  • GLP/ GCP/ GDP Audits: In addition of GMP Audits, BMEPC Group also conducts Audit of Development and Analytical Laboratory, CRO, Warehousing & Distribution Network.
  • Bulk Audits/ Shared Audits: BMEPC also offers unique business models whereby manufacturers of APIs, KSMs, Excipients can significantly reduce their load of Third Party Audits and consequent CAPAs.
  • Quality Due diligence: BMEPC Group offers Quality Due Diligence support facilitating company’s review their facility from Compliance & Investment perspective.
  • Supply Security Audits: Implementation of EHS Audits are important element from environmental management perspective. BMEPC Group with its team can assist companies for EHS Audit.

BMEPC does not limit itself only to offering Audits, we expand our solution offerings to ensure complete Compliance at Client’s site. Towards obtaining GMP Certification from different regulatory bodies, BMEPC has a very effective, systematic and rationale approach in providing solution efficiently. BMEPC operates on a turnkey basis and gets involved completely ensuring success to its clients, which is the overall objective.
  • EU/WHO PICs: With increase in the outsourcing of Finished Products, APIs, KSM from Asia there is a sudden surge in compliance demand. BMEPC with its team of auditor can provide end-to-end service and facilitate in getting client’s facility approved by competent EU/ AU/ WHO/ PIC/s Authorities and realizing their objective for establishing their potential presence in International Markets.
  • CAPA support: More than non-compliances per se, the pattern of the non-compliances reveals the holistic CAPA to be established. BMEPC with its ample experience on Remediation and experience on handling a number of Authority Inspections across the world firmly believes in the flawless execution of the CAPA, followed by its closure.
  • GMP Compliance Training: BMEPC organizes extensive training sessions for all its clients covering all areas of Compliance. While trainings are conducted, wherever needed after the audits, BMEPC also arranges training sessions for QA and Manufacturing personnel of clients, keeping them abreast with latest regulatory requirements and market challenges.

All Dossiers as listed

With the growth in pharma manufacturing capability in developing market, each manufacturer nurtures an ambition to have their own footprint in the developing market. BMEPC , with its own setups in across globe, has created a platform which provides a comprehensive, integrated and seamless market access and supply chain solution with the needed infrastructure for FDFs, APIs and Allied Products, right from the site of manufacture to the end point of the distribution chain in compliance with EU GDP guidance and on a cost-effective basis.
The following services are integral to the Market Access solution of BMEPC.
  • DMF Preparations/Submissions
  • Dossier Preparations/Submissions
  • Pharmacovigilance
  • MA Holding
  • EU Importation & Batch Control / Batch Release
  • Scientific Advice
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