Our reliable experts will ensure you receive the best advice and help to get your products to market
Companies looking to establishing themselves in Europe want an independent expert to advise and help during the initial and final stages of development. As consultants, we're often brought in towards the end of a project to complete dossiers and submit them to the regulatory agency. This usually takes between six and
nine months.
Individual experts or development teams can be tailored to suit a
particular project.
Independent support for your team
There are many benefits of bringing in external experts.
At best they inspire existing staff and provide leadership when business direction is uncertain.
QA interim management can be a temporary replacement for a senior member of staff, or ongoing assistance for emergent companies seeking to establish a European office.
You might require a senior technical director to manage the transfer of technology from a research environment to a manufacturing and marketing domain.
We can also provide senior management roles to represent your factory to potential clients. We'll liaise with the purchasing group and produce proposals and costs along with a product plan.
A management service can also be provided for a particular project, such as development of a new documentation system.
Interim Management consulting
flexible expertise when you need it
Michael Gamlen MRPharmS PhD
Pharmaceutical Consultant
and Managing Director/founder of PDS
"I provided interim QA Management for a small biotech company on a part-time basis. Following an initial six-month contract, they renewed the contract for a further six months, then for a further year.
The client received the benefit of continuity and avoided
expensive overheads."
"A major company asked for advice on timing of analytical activities for the first clinical trial of a new drug. I gave independent advice on what needed to be done, which was greatly valued.
This minimised unnecessary expenditure by the company.
The client continued to rely on my advice for the latter stages of clinical trials and the marketing application."
Adverse event tracking
Biotech QC specialist
Clinical trials manufacturing
Contract QP
Contractor management
PAI preparation
Electronic publishing
eCTD systems
GXP auditing
Herbal medicines
Inspection preparation
Interim management
Laboratory management
Medical device registration
New product introduction
Outsourcing
Packaging and labelling
Particle science
Pharmaceutical development
Project management
Quality management
Qualified Person services
QP certification
QP release
QP support
Regulatory affairs
Regulatory due diligence
Training and development