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



Business Development


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

Competitive analysis

Draft or review of business plans and expansion plans

Merger/acquisition product development technology valuation

IP review





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).