Our Compliance Proposals should fulfill your needs and your professional expectations - even at this early stage of a possible project work. We are analysing your project requirements for resource management, technical and procedural needs, scheduling, and regulatory compliance issues. We will create together with you an inexpensive and flexible road-map to compliance. We assist you in getting ahead with your business challenges, clear project success and personal career.

A project with us can be devided into several project sections with clear performance milestones or sub-projects. You define amount and area of work, project structures, team setup, and expected deliverables.

Typically our proposals include following pricing levels:

1. Negotiated Fixed Price: based upon a mutually agreed value of the results to your business; travel and material costs are usually included.
2. Performance Based: similar to the fixed price option, but billed out at 75% of the normal rate; you determine the remaining payment based on your level of satisfaction (Bonus-malus system). Works best in compliance to the condition of an existing project plan, and pre-defined mile stones & agreed deliverables.
3. Time & Materials: based on an hourly rate and a total estimate, usually on monthly performance reports, plus travel and materials expense.

We offer to you a transparent billing based on monthly records. Our invoicing is flexible to meet your accounts-payable and budgeting needs; simply let us know the information you need.

Tired of being sold the A team only to have the B team shown up?

Clients work directly with our Managing Director and Principal, Markus Roemer, a globally recognized expert on IT projects and computer system validation.

Markus Roemer is:

• an active ISPE member and ISPE Ambassdor of the DACH Affiliate.
executing trainings since more than 6 years and trained 500+ persons in the fields of IT and computer system validation, development and quality management.
• the founder of the organisation "IT Pharma Validation Europe".
• according to the German Medical Devices Act a certificated "medical device consultant" (refer to §31 German medical device act).
was according to ISO 9001:2008 - quality management systems - assigned to the role of a Quality Management Representative.

We are able to set up different special offers and package deals with our Focused Solution Packages (FSP).

What To Do Next

Contact us today. Or read more about our service approach and solution for test,validation, or training management.

Start your Live Proposal Request right now.