Outsourcing Services

Management Services for Outsourcing of Research and Manufacture.

We offer a range of management services to support companies who have taken a decision to outsource research or manufacture. For example, a company may wish to seek partners for any other following:

  • The production of APIs, chemical intermediates
  • The development of pharmaceutical formulations
  • The manufacture of pharmaceutical formulations for the market
  • Pharmaceutical testing
  • Clinical design
  • Research activities such as process design and formulation development

Some advantages of outsourcing are:

  • Freeing up existing manufacturing resources for new projects
  • Acquiring expertise and knowledge not available in-house
  • Moving older products to a lower cost platform
  • Penetrating new overseas markets by manufacturing and supplying your projects closer to those new markets
  • Expanding your supply base

The successful placement of outsourcing projects depends on effective analysis, planning and execution. Our experience of managing contractors has taught us that there are a number of important processes (listed below) that ensure successful outsourcing. These processes are available as management services from ActexPharm either individually or in combination with each other.


ActexPharm Outsourcing Lifecycle

Parallel activities associated with some outsourcing projects include:


ActexPharm Parallel Outsourcing Activities

*if not using contractor's method of synthesis

At the outset, we take great care to identity your needs and expectations in outsourcing. We assess the technical, regulatory and compliance requirements of the project, as well as time and budget goals. Many project failures are caused by inadequate analysis and planning at the initial scoping stage of a project.

Our range of contractors is drawn from a mix of companies based in Europe, North America and India. The proximity of a particular contractor to a specific market may be important in the choice of an outsourcing partner. We seek to find partners who are technically proficient in relation to a particular API or formulation but who also have considerable skills in communications, project delivery as well as adhering to commercial agreements and budget targets.

In a highly regulated environment, we provide suppliers with considerable expertise in producing and managing information flows and documentation that meets with ICH, FDA and EU regulatory approval. If the project demands, we can organise Drug Master Files (DMFs) or obtain the necessary information to update your existing DMFs.

We can organise on-going monitoring of the GMP and ISO compliance of contractors and suppliers and ensure timely reports on compliance by pre-agreed dates. We can also assist you by improving commercial relationships with contractors and by seeking cost improvements for processes involved in the manufacture of an intermediate or API for final formulation.