PHARMA MANTRATM

Delivering strategic and transformational Quality leadership drive for imparting Culture of Pharmaceutical Quality to provide successful international growth initiative to following Clients with Global Footprints -

• Active Pharmaceutical Ingredient - Sterile, Potent, General

• Pharmaceutical - Orals, Parenteral, Semi-Solids, NDDS, Bio-similar

• Devices - Wearable, Implants, Surgical

• Contract Testing Laboratories - Microbiology, Chemical & Instrumental

• Contract Manufacturing Organisations - Orals, Parenteral, Semi-Solids, NDDS, Bio-similar

• Healthcare,

• Software

• Toxicological Assessments- Permissible Daily Exposure Limits (PDE) Certification

Provide effective leadership for Quality Management of Manufacturing and R&D operations. Performing the desired GAP assessment, bridging the missing links, mentoring the remediation program, by hand-holding the operation team. Providing an interface between the Top Management with the Operational executives.

Guidance and Training to the management and operations team on regulatory and quality requirements and strategies to adhere and maintain compliance and SOC. Specifically focusing on -

• Data Integrity,

• Hosting the Regulatory Inspections,

• Quality Culture and expectations,

• Investigations, Root Cuase Determination & CAPA,

• ICH Guidance and

• CGMP.

Steering organization through complex Quality & Regulatory challenges, remediation, transitions & building an empowered Quality Operations Team which is capable and empowered to deliver results within highly competitive products and regulatory environment.