Our

Services

Consultancy Services

Our highly specialized and cross-disciplined team offers a broad range of services for pharmaceutical, biopharmaceutical and medical device companies. These services include:

      • Quality system Robustness Appraisal

Performing GMP quality system appraisal and resolving any findings to ensure quality system in compliance with the regulatory guidelines.       

  • Facility Operational Fitness Assessment

Assessing the operational-readiness of GMP biopharmaceutical / pharmaceutical facility for drug manufacturing.

  • Regulatory Compliance Remediation 

Identifying and resolving any compliance issues/gaps of the GMP manufacturing facility.

  • GxP Training Workshop & Quality Behaviour Coaching

Developing and conducting workshops according to the companies’ training requirements as well as coaching of staff to improve/enhance quality behaviour.

  • GLP Laboratory Renovation

Providing project management from conceptual design, tender preparation, renovation, commissioning/testing till project hand-over to clients.

  • Validation

Preparation of validation master plan, qualification protocols (IQ/OQ/PQ) and managing various validation activities of the GMP facility.

  • Project Management

Managing various aspects of life science and biopharmaceutical projects including technology transfer, GMP facility renovation, validation, process development  and production campaign.

  • Product Commercialization

Developing business strategy and supporting clients in finding potential strategic partners.

 

Contact us for a personalized solution.