Afra Pharma Consultant
|Afra Pharma Consultant|
|Industry||Regulatory Affairs Industry|
|Key people||Mir Sadat Ali,Managing Director|
Afra Pharma Consultant (APC) is a private limited company based in Pune, India. APC was established in 2011, and is the leading provider of quality resource for the regulation of pharmaceutical products (including those deemed as consumer Health and OTC). APC dedicated team is comprised of consultants with great experience of over ten years in all aspects and at all levels of regulatory affairs in the worldwide markets. The services are designed to meet all of the latest regulations, helping clients to meet all of the stringent requirements of the pharmaceutical world.
The company is managed by Mir Sadat Ali, who has been involved in the Regulatory Affairs industry for over 9 years in Saudi Arabia and has been there in all transit phases of regulatory changes from Ministry of Health to Saudi Food and Drug Authority to G.C.C. He has also successfully completed and worked on the projects like joint venture, technology transfer and finished products company registrations in the Middle East.
- Regulatory & Dossier Support
- Medical Devices
- Clinical Research Organization
- Ba/Be Studies from approved US FDA and GCC CROs.,
- Clinical Trials
- Contract Manufacturing
- Pharmacovigilance Services
- Technology Transfer
- In & Out Licensing
- Import/ Export
- Pharmaceutical Turn-Key
- Pharma Training
- Information Technology
- General Services
They provide medical & drug safety services to pharmaceutical companies across the globe. Their expert team consisting of senior advisors, physicians & Pharma covigilance professionals. They offer end-to-end pharmacovigilance support for global pharmaceutical companies and clinical trials involving all therapeutic areas and to emerging pharmaceutical companies to develop and maintain their drug safety systems.
Providing high quality drug safety services to Pharmaceutical companies, Research organizations and health agencies.
Drug Safety Services
- End-to-end Case Processing (ICSRs) – case intake and triage, MedDRA coding, narrative writing and medical assessment
- Aggregate Reporting (PBRER/PSUR, PADER and DSUR)
- Preparation and submission of Periodic Safety Update Reports (PSURs) to Competent Authorities
- Writing of Risk Management Plans (RMP) / Risk Evaluation & Mitigation Strategies (REMS).
- Benefit-Risk assessment and communication to Regulatory Authorities and Healthcare Professionals
- Signal Detection & Management
- Preparation, review and approval of standard procedures for PV system
- Literature search
- Worldwide Literature screening through automated literature screening module
- Clinical Trial Safety Management
- Medical Information (including Call Centre Support)
- Regulatory Safety Assistance (pre & post-authorization)
- Standard Operating Procedures (SoPs), Working Instructions (WIs) & Guidance Assistance
- Audits & Inspection support
- Training & Consultancy
- Implementation of CAPAs
- Pharmacovigilance System Master File (PSMF) Preparation
- Turnkey Projects in Pharma covigilance