Our highly specialized and cross-disciplined team offers a broad range of services for pharmaceutical, bio-pharmaceutical 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.
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.