Pharmaceutical Consulting Services

 

Orion GXP Consulting is a pharmaceutical GDP and GMP Consultants service for the UK, Ireland and the EU. Our company has extensive experience in quality and regulatory oversight of pharmaceutical import, production and distribution. Our expertise includes solid and liquid oral formulations, topical creams/ointments, ophthalmic products, aseptic filling and terminally sterile products.

 

We provide the following specialized contracting, staffing, and consulting services to the healthcare industry:

Qualified persons pursuant to Article 48 of Directive 2001/83/EC.

Responsible person according to the EU GDP Guide (2013/C 343/01).

GMP and GDP Mock Inspections, On-Site Audits and Supplier Certification.

Pharmaceutical QMS development, implementation, and integration.

Training in key areas such as root cause analysis, batch testing, auditing, data integrity, and quality risk management.

Pharmaceuticals Assists with MIA and WDA license applications.

Due Diligence and Gap Analysis for Mergers, Acquisitions, and Spinoffs.

 

At Orion GXP Consulting, we can support our pharmaceutical clients when they require additional resources by leveraging our network of industry experts, including statutory roles such as Representative and Import Representative.

The MHRA created the role of Responsible Person (Import) RPi as there is a need to repeat the controls carried out by the EU QP, which is bureaucratic and unnecessary. This allows UK companies to obtain his EU/EEA QP certification and import and import products. Importing publications under a Wholesale Distribution Authorization (WDA).

 

We decided to start the new year with a conversation about the role of RPi and its importance with Nim Tully, our Deputy Director, Principal Consultant/Import Officer and our newest employee.

 

When you started working as an RP/RPi consultant, what surprised you about consulting? And how is it different from working in a full-time position in the industry?

 

Most importantly: I think I was able to provide flexibility not only to my clients but also to myself. It was very interesting to see each client at different stages of the process. Some customers are in the early stages and need to submit claims, while others are already established and require ongoing support.

Additionally, when you work full time for a company, you don't get to see all the other ways of working and the stages the company is at. You are on a journey with this company.

Now we have clients at every stage of the process, and it's very interesting that no two clients are the same. Everyone needs my support in different ways.