We create a unique process for each client to ensure that business objectives are met and success is achieved!
A Complete Solution For Your Business
Step By Step
Problem solving/root cause analysis/process efficacy improvement for recombinant protein and DNA process research, development and cGMP production
Formulation development/scale up for complex formulations (peptides, lipids, polymers, medical devices)
CMO contract negotiations/agreement review/project management/onsite supervision
CRO project coordination, ensuring supplies and projected preclinical studies are carried out on time
cGMP Facility specification/design/construction supervision
cGMP Facility qualification/validation project management/execution
CMC/IND preparations and review
CMO on site and paper audits
FDA meeting attendee as product development representative for small organizations
Regulatory for veterinary products with US FDA, CVM or USDA
We can offer a US base/office/representation for European or Asian organizations attempting to increase business in the US or file for US approval
Negotiation of manufacturing alliances
Draft or review of business plans and expansion plans
Merger/acquisition product development technology valuation
Clinical outsourcing and procurement contracting for Pre-clinical toxicology, Phase I-II (clinics and laboratories) and Phase III-IV projects/ programs.
Negotiate major strategic alliance/ preferred provider and master service agreements.
Evaluate service provider candidates for business partner projects/ programs.
Interface between executive and project management business partners and local/ global contract research organizations.
Introduce rigorous process analysis tools and performance metrics as methods to improve data quality, to streamline back-end delivery systems and to maximize financial performance.
Interface between business partner personnel and IT service/ integration provider(s).