Biotech consultancy - Pharmacology, Toxicology, Preclinical, IND
Scientific, Regulatory and Strategic Consulting for Biotech

Clients

From California to Scandinavia 

Existing and Past Clients
 


Start-Ups / Emerging Biotech

  • US and EU, oncology focus;
  • Development of non-clinical development plans (pharmacology, toxicology, PK); input to clinical plans and protocols; Protocol design and development;
  • Pre-IND meetings and other communications with the US FDA; Preparation of IND applications for the US FDA;
  • Planning and preparation for dual regulatory submission packages involving the Chinese FDA (CFDA);
  • CRO selection; GLP study auditing; mock inspections;
  • Assist in CMC;
  • Input into funding / grant applications; China partnering;
  • Strategic and operational input.
  • Several peptide IND packages. 

Global Top-10 Pharma

  • CRO selection and utilization, program and protocol design;
  • Mock inspections;
  • Study auditing.

Global Chemicals Company

  • CRO selection and utilization, program and protocol design;
  • China strategic advice.
 

Working With Me
 

 

  • An absolute confidentiality is assured to all of my clients;

 

  • I am an independent consultant and do not accept any financial incentives from CROs I work with;

 

  • The projects are charged either by hourly basis or by fixed project based fee. The latter is especially useful for larger projects such as IND packages;

 

  • Even though the consultancy is China-based, there is usually no need to charge extra for overseas travel, if the occasional face-to-face meetings can be scheduled to coincide with some of the frequent trips to the US and the Europe (most clients are US and EU biotech companies);

 

  • Outsourcing solutions are not exclusive to China - I also work with Western CROs. However, I believe China is the right approach for any pharmaceutical company: the total cost of a typical preclinical project (US IND) can be reduced from US $1M to $300,000, while the quality with proper CRO selection and oversight, can be comparable to any Western CRO.  At the same time, if the preclinical package and the API manufacturing are done in China, it opens possibilities to e.g. clinical development, out-licensing or funding in the country.
 
 
Harri was able to successfully run a massive ‘Animal Rule’ study for us in China. The cost for this US FDA-approved study was less than $1M, rather than $3.5M in the US.
— CEO of a US Biopharma Company.