Some of the Areas we Have Expertise in:

Regulatory Services with eCTD

GDP Compliance – Gold Standard RP + RPI

SME Focus

Virtual Company Focus

PV: QP PV & Med Info

“Brexperts”

UK QPPV

UK Cosmetic RP

UK RPI

EU & UK Regulatory

UK MD Quality Management Representative

Variations

Renewals

Sunset Clause

61(3) (Artwork)

Duplicate Licences (10c)

Sunset Exemptions


Manufacturing and Analytical Technical Transfer

Practical Focus

Analytical Validation and Lab-to-Lab Transfers

QP batch certification

MIA (Human)

ManA (Veterinary)

GMP Certification

Nitrosamine Risk Evaluation


Our History

We started the company in 2000, focussing on traditional QP release work. By 2007 the company employed 6 people, having expanded the technical capability to include all aspects of pharmaceutical consultancy work. In 2008 we were granted MIA 29498, enabling us to import and QP release products from outside the EU/EEA into the EU/EEA. Since 2009 we have held several marketing authorisations in our name (MA 29498/—-) on behalf of 3rd parties. In 2018 we were granted ManA 29498, for veterinary product importation and QP release.

As of 2020 there are 10 employees (full & part-time), and 1 regular subcontractor (2 people). Six people work at degree level or equivalent. Six employees have worked here for at least 10 years.

We have been involved in multiple Competent Authority and Third Party inspections/audits with no critical findings. We have a dedicated and long-serving team of experts and a network of specialist contacts within the industry. We work with clients from all over the world, and organisations of all sizes and shapes. Over half of our clients have been working with us for at least 10 years.

Antony Wakeford and Lorraine Bedford are the only Shareholders.


Lorraine Bedford

Director

Member of The Organisation for Professionals in Regulatory Affairs (TOPRA).
BEng (Hons) 2:1 Engineering & Engineering Systems (Portsmouth).
4 A’ Levels (Business, Maths, Physics, Chemistry), 1 AO Level, 9 O’ Levels.
Various other courses including: Pharmacovigilance, EVWEB, Training the Trainer, GMP, GLP, and PIL User Testing.
Advanced IT skills, group and individual training specialist, systems validation, World Class Manufacturing (WCM), Quality Systems development, Quality Assurance, auditing & engineering design.
Qualified Person for Pharmacovigilance (QP PV).
Quality Management Representative for Medical Devices.
Responsible Person for Cosmetic Compliance.
Over 25 years experience in industry.

Email me: Lorraine@QP-Services.com

Antony Wakeford

Director

Member of the Royal Society of Chemistry – Chartered Chemist.
Graduate of the Royal Society of Chemistry, GRSC Parts I & II.
MSc Instrumental Analysis.
Postgraduate Diploma in Industrial Pharmaceutical Studies.
Postgraduate Diploma in Occupational Health and Safety Management.
HNC Chemistry, ONC Sciences (elective chemistry).
Various other courses including: Management Skills Development Programme, Pharmacovigilance, QA Auditing, Statistical Process Control, FDA Compliance, GLP Compliance.
Qualified Person Status granted February 1993, Directive 2001/83/EC and 2001/82/EC.
Qualified Person named on a number of MIA / ManA licences.
Qualified Person for Pharmacovigilance (QP PV).
Responsible Person for Good Distribution Practice names on a number of WDA.
Quality Management Representative for Medical Devices.
Responsible Person for Cosmetic Compliance
Over 35 years experience in industry.

Email me: Antony@QP-Services.com