R&D Consulting - Due Diligence

Aginko Research experts can be contracted to assess various technologies and their market potential. 
Frequently we have been included in due diligence teams in cases of a merger of acquisition for orthopaedic technologies/compounds.

Strategy, Analysis, and Development  

  • Predicate landscape and device design
  • Balancing indication costs and claims
  • Leveraging regulations, competition, and new opportunities
 

Benefits of Our Consulting

  • Fast and efficient through clean targeting
  • Independence and objectivity as 3rd party consultants
  • Highly experienced technical consultants
  • Deep operational experience
  • Ability to rapidly mobilise and deploy the Technical Due Diligence (TDD) team
 

Typical Scope  

TDD typically includes an assessment of Medical devices or Drugs in the field of Joint Disease. Our focus makes the difference compared to a general TDD consultant. The ability to bring market knowledge is our asset.

We conduct also DD on acquisition of Healthcare Providers.

All of these services are achieved through a closely managed process of focused, rapid data collection and assessment of the installed assets, systems, people, and practices.

Regulatory Know-How

We specialise in helping medical device companies, pharmaceutical companies, and healthcare institutions comply with international regulations. As a result, we are extremely familiar with the following medical device regulations and can perform audits to determine the extent of compliance with:

  • USA – US Food and Drug Administration regulations
  • Europe – European Medicines Agency regulations, Medical Devices Directives and CE Marking
  • Japan, China, and South Africa regulations
 

Strategic Advice

Aginko Research assists its clients by providing­ strategic ad­vice on many aspects of their drug development and medi­cal device programs.

Strategic advice is provided by the in-house personnel supplemented by our network of external consultants, as appropriate.

Regulatory Affairs

Bringing a new product from development to market approval is an expensive and lengthy process. If unanticipated delays occur, costs in both time and money can rapidly escalate.

Whether your new product is a drug, a biological product, a device or a combination, our experienced colleagues are ready to work with you to set and help deliver on aggressive timelines that control costs.

The regulatory expertise at Aginko Research can benefit your project during all phases of development.

Clinical Trial Services  

  • Advice on regulatory procedures
  • Preparation and submission of clinical trial applications (CTA)
  • Local accompanying of the approval process and communication with regulatory authorities
  • Provision of official documents, specific procedures and translations
  • Drug importation for clinical trials incl. narcotics
  • Submission of IDE; PMA; BLA, 510 (k); HDE; Pre-IDE/BLA, Panel Meetings
 

Medical Writing

Aginko Research experienced medical writers provide the following medical writing services:

  • Protocol development and writing
  • Subject information and informed consent forms
  • Integrated clinical and statistical reports according to the ICH-E3 guidelines
  • Translations of medical scientific assays 
  • Case report forms and patient diary development 
  • Subject narratives
  • Other relevant medical documents, e.g. handling and working manuals for CRAs 

Our team provides a full range of medical editing and writing services for all our client’s clinical trials.

Osteoarticular and inflammation focused preclinical and clinical research organisation (CRO)

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Contact Us

Contact

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info@aginko.com

Route de l'ancienne Papeterie 106
1723 Marly
Switzerland

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for contracts signed between the 2nd and 12th of december

Sign a contract and receive a 40% discount off the total study