Pharmaceutical/Biotechnology Consulting Services

AspecX is a specialist in the field Pharmaceutical/Biotechnology. Possessing Core Technical expertise that oversee the Quality, Regulatory and Engineering aspects of Pharmaceutical and Biotechnology processes. Some of our Core Competencies include:

cGMP Regulatory Compliance - In the highly regulated Life Sciences Industry, manufacturers have to adhere to Current Good Manufacturing Practice (cGMP). Through GMP assessments or even Pre-Approval Inspection audits, AspecX can ascertain that your current manufacturing process, in production, QA and QC are compliant with the guidelines and standards set by your local, or international authorities, including PIC/S, US FDA, EMEA and TGA. For areas that are non-compliant, AspecX can suggest solutions through one of our other services such as Business Technology, IT/IS/ Automation Services, Strategic Management, Validation, or Operational Management.

Validation - Validation gives a high degree of assurance that the Installation, Operational functions and Performance capabilities of the drug, therapeutic or medical device manufacturing process conform to the design specifications on a consistent basis. AspecX's approach to validation of equipment and processes requires thorough knowledge of all devices and failure modes, clear acceptance criteria and strict control of changes to services and equipment under a change control regime.

Process Equipment Design and Specification - With in depth knowledge of the workings of pharmaceutical production equipment, and biotechnology processes, AspecX can put in place a biotech process from fermentation, to downstream processing and purification, or a chemical process from Reactor to Purification and Secondary processing. AspecX is familiar with a host of equipment including fermenters, reaction vessels, tablet presses, blenders, autoclaves, chromatographic columns and centrifuges.