Successful companies thrive
as a result of hard work and dedication – let us contribute our skills to your success.
Our Proposition
Management and Business Consulting
In addition to strategy development and preparation of business plans, we also offer change management, coaching and strategy implementation services. Financial management services such as venture capital brokerage and grant funding advice further complete our service offering, together with company valuation and full project management, to include planning, implementation, team management and professional communication.
Non-Clinical Development
We work with you to develop the preclinical development strategy for your product and jointly we carry out the non-clinical development. We support you in the preparation and submission of all regulatory documents (IND, CTA, IMPD, NDA, BDA, CAP) both within and outside the ICH area. We take responsibility for the identification of the right CROs to ensure the adequate quality standards (GLP, ISO). We advise and support you in the implementation of quality assurance systems in preclinical development (QA, GLP, training seminars, audits).
GMP / Quality / Regulation
We take over the creation, review and approval of GMP documents such as SOPs and manufacturing instructions or specifications, ensuring GMP compliance and checking for deviations, change control and OOS before initiating release. We create and control regulatory documents for authorities such as FDA, EMA, PMDA or AGES.
Operational Management
If required, we take over operational management for the development, trading and distribution of medical devices. The formation of a company is possible even if none of the founding members can provide the required verification of experience for company registration. Operational management can also be provided on a part-time or locum basis, which can be particularly useful in the start-up phase of a company.
Scientific Affairs
Evidence-based marketing is crucial to business success. We prepare your scientific results professionally and publish them in relevant professional journals. We take care of the entire patent management process, from research and analysis (Freedom to Operate – FTO) to providing technical expertise. Further core competencies include technology transfer, competitive intelligence and the identification of competitive fields.
Marketing and Sales
Our service offering includes the analysis and evaluation of existing concepts, sales optimisation, employee training, and support with product launches, branding initiatives and customer events. In the area of product development and life cycle management, we focus our expertise on customer surveys, product management and improvement as well as pipeline strategies to identify opportunities for up-scaling and spin-off. We are experts in all aspects of sales support including expansion into international markets.
Biosafety
In addition to providing advice on issues of biosafety and genetic engineering, we also offer extensive expertise on biological agents and genetically modified organisms (GMOs). We provide support for compliance with statutory requirements and also deal with any issues relating to biosafety, for example in the area of animal welfare. In addition, our services include the provision of seminars, lectures, training sessions and workshops as well as supervisory functions.
Interim Management
In addition to conducting strategic consulting, we are also able to support you with operational implementation where required. During a period of professional consulting involving change, human resources or specialist expertise can sometimes be lacking. At times like this, it can be useful to take advantage of our Interim Management service.
Due Diligence / Situation Audit
If you are looking to invest or divest an equity interest in a company or wish to license a product, then we are able to assist you with an initial situation audit and in-depth due diligence to help you avoid the potential associated risks and ensure you make the right decision.
Start-up Package
We evaluate your business idea and give you qualified feedback at the earliest opportunity, on the potential viability of your project. Our experienced team creates a business plan for your start-up project, for submission and implementation with the appropriate development grant office, and is always available to you for advice and guidance.
