A Pharmaceutical Quality Consultancy Service Provider For GXP Services.
Vinayak Pharma Consultancy Limited (VPharma) is a Quality Assurance consultancy specializing in Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Auditing and Quality Management System (QMS). VPharma provides QA services to Pharmaceutical clients and MIA Holders to support all areas of Quality Management System.
Contact UsAbout Us
- Vinayak Pharma Consultancy Limited (VPharma) is based in Dublin (Ireland).
- The QA Consultant at VPharma has over 17 years experience in pharmaceuticals.
- This includes; Drug Substances/API, Bulk products, FDF Drug Products (Solid oral dose, Sterile products, Lyophilized products, Liquid, Syrup, Ointment, Ampules, Vial, Powder, Sachet).
- The QA Consultant at VPharma is eligible to act as a Qualified Person (under Directive 2001/20/EC, 2001/83/EC and 2001/82/EC), is eligible to act as a Responsible Person (under EC 1223/2009), IRCA certified Lead Auditor for Quality Management System (ISO9001:2015), and Certified for ISO/IEC 17025.
- VPharma provides support to clients in the UK, Ireland, Europe, India and USA.
Mission and Vision
Our mission is to provide superior quality services by understanding the needs of our clients and providing the highest quality products to our end user.
Our Services
QP Services
VPharma provides QP Services as a contract QP on the MIA License of the client. This can be onsite or on a remote basis.
To provide the above services, the VPharma QP will undergo training on the client’s Product(s), Process(s) and Quality System. This includes the full supply chain Quality System and preparation for batch release activities. This training will be carried out onsite or remotely as required.
NOTE: VPharma also provides API Declaration Services, PQR Review Services and Stability Review Services as required by the client.
All QP services will be provided to the highest GMP standard.
RP Services
VPharma provides RP services as a contract RP on the WDA License of the client. This can be onsite or on a remote basis.
To provide the above services, the VPharma RP will undergo training on the client’s Product(s), Process(s), Quality System. This includes the full supply chain Quality System and preparation for batch release activities. This training will be carried out onsite or remotely as required.
All RP services will be provided to the highest GDP standard.
Auditing Services
To perform an audit, it is essential for VPharma to have an MSA (Master Service Agreement), CDA (Confidentiality Disclosure Agreement) and QTA (Quality Technical Agreement) prior to further continuation.
Once the above are in place, an audit date(s) will be agreed, an audit agenda will be circulated and the pre-audit documents will be requested from the client and reviewed in advance.
The audit will be performed and a report will be provided.
VPharma also offers Health Authority Audit support services, which includes Pre-Audit Preparation, Audit Participation and Post Audit Response Review.
QMS Services
VPharma will provide the highest quality QMS services to maintain a low KPI (Key Product Indices) count for the site quality council.
VPharma QMS services include;
Change Control, Deviation, CAPA (Corrective And Preventative Action), Customer Complaints, Investigation Reports, PMSI (Pre Market Supply Incident) and CQN (Critical Quality Notification).
This can be arranged onsite or remotely.
Interim QA Management
VPharma will strive to provide exceptional Interim QA Management, as per the requirements of the client.
This can be onsite or on a remote basis.
The scope of the Interim QA Management will be discussed and agreed on a case by case basis.
Product Launch Services (In Europe)
VPharma will offer QA support to launch a commercial Drug Product to the EU market hand in hand with the Launch Management team and the Supply Chain team to meet the deadline.
This can be onsite or on a remote basis.
Quality Oversight for Third Party Products
VPharma will make sure Third Party Contract Manufacturers offer the highest standard product, which is inline with the EU GMP Guidelines.
This can be onsite or on a remote basis.
Tech Transfer/Method Transfer Services
VPharma will ensure the best outcome with its Tech Transfer/Method Transfer services.
Analytical Method Transfers & Validation of Non-compendial methods as per ICH Q2(R1), USP<1224> and EU GMP Chapter-6.
Pricing
Our first consultation is free of charge, whatever the outcome. Once an offer is made, we will provide a cost estimate. There will be no charges on your side, until we receive your order in writing.
Depending on the type of work, our charge estimates usually have one of the following formats and we are open to adjust to your needs;
Fixed Charge per hour (Onsite or Offsite)
Example
- Contract QP
- Contract RP
- QMS improvement project
- PQR review
- Stability review
- etc
Fixed Charge per hour and domestic charge (Onsite Only)
Example
- Onsite Audit
- Onsite QP release
- Tech Transfer
- Client visit
- Third Party Audit
- etc
Our Team
Director
Dr Joravarsinh (Joe) Rana
PhD MRSC
Education
PhD in Chemistry
Masters in Industrial Pharmaceutics (RCSI & IT Sligo).
PG Diploma in GMP and Biopharmaceuticals (TU Dublin).
Completed various other courses including: Certified Lead Auditor, Certified RP, certified for ISO/IEC17025.
Experience
Over 17 years experience across three countries India, UK & Northern Ireland and Republic of Ireland.
joerana@vpharma.ie
Joravarsinh (Joe) is a PhD Qualified Senior Pharmaceutical professional and a leader with extensive experience in the Global Pharmaceutical Industry across three countries.
Joe is the Founder and Director of Vinayak Pharma Consultancy Limited (VPharma) and a member of the Royal Society of Chemistry UK (MRSC). Joe acts as the primary consultant and leads the VPharma Team.
He has experience and competency in Quality, Team Leadership, Auditing, and he is a Qualified Person. Specializing in QMS, Auditing, Problem Solving, Product Launch and Third Party Quality Oversight.
He is an acting QP on the HPRA MIA License-SOD FDF Drug products; Certified Lead Auditor, Experience in Liquid FDF DP & API Testing; Certified ISO17025; SME on QMS; Certified RP (Responsible Person).
His skills include Leadership and Management. He has previously hosted, participated in and prepared for regulatory GMP audits with MHRA, HPRA, FDA and Third Parties.
Secretary
Mrs Daxa Rana
M Com
Education
Masters in Commerce with Advanced Accountancy.
Bachelors in Commerce with Advanced Accountancy.
Certified Computerized Accountant Level-1 and Level-2 from City & Guild UK.
Experience
Over 10 years experience across three countries India, UK & Northern Ireland and Republic of Ireland.
daxarana@vpharma.ie
Daxa is a post graduate in commerce and has an extensive insight in advanced Accountancy and Retail Office Management in three different countries; India, UK & Northern Ireland and Republic of Ireland.
She is responsible for the accounts and administration of VPharma and assures that all clients receive the best administrative service.
Contact
Our Address
Vinayak Pharma Consultancy Limited
220-Drumnigh Manor, Portmarnock
Dublin, D13W68A, Ireland