Life Sciences Startups

We provide following consulting services to life sciences startups.

Compliance Progression and Quality Metrics

The latest guidelines on quality metrics introduced by FDA envisage a reduction in the frequency of inspection by upgrading the quality metrics parameters. We adopt the quality metric tools driven by SharePoint technology to meet the progressive regulatory requirements in the future.

Quality and Regulatory System

Source Consulting pursue the latest regulatory trends and quality system to clients to ensure consistency in the quality of products. The surge in competition in the life science industry and a dynamic regulatory situation requires enhanced programmes in quality issues to realize revenue expectations. We integrate our annual goals on quality with that of our clients to reap mutual benefits.

Documentation to Ensure compliance with Quality Metrics

Source Consulting provides assistance to clients to transform raw data into tangible metrics and trends of the processes in use. By utilizing data driven quality metrics initiatives we enable our clients to perceive the invisible but expected quality outputs from their process. We have successfully integrated data driven vendor, internal audit, and training and compliance managements to our client sites. Our motto is becoming an integral part of a system ahead of effecting changes.

Record keeping and Management

Record Keeping and Management is one of the cardinal components of a quality environment and influences directly the parameters of performance and quality of products. Proper documentation ensures a disciplined approach to personnel engaged in manufacturing, training and as a reference to execution of the processes involved. Our axiom is “Do what is documented and document what is executed.” We facilitate digital archiving solutions to life science industry so as to ensure effective follow up and demonstration during regulatory audits.

Risk assessment and GAP compliance Prediction

As a leader in regulatory affairs, Source Consulting is the consultant of choice for industries in the field of pharmaceutical, biotechnology and medical devices. We believe in practicing the concept of quality by design and risk management to ensure quality in operations. We assess various operations such as training, vendor management, lot disposal and quality trends with the help of risk assessment tools to facilitate easy progression on future steps.

Documentation of SOP

Source Consulting is well versed in documenting SOP for Quality Systems, validation and compliance processes, and manufacturing. We assess the compliance GAP by reviewing the prevalent processes, along with cross reference within documents and interdepartmental procedures. Our professionals confirm that written documents comply with current regulations and guidelines and are synchronised with the best practices in the industry.

Annual training

Regulatory bodies have articulated intense interest in training to ensure adherence to GMP in manufacturing and we ensure annual GXP training to employees engaged in manufacturing. The training tools are updated annually incorporating the latest advancements provided by training manuals. The annual GXP trainings are a valuable exercise to enhance competencies of employees and are also essential to regulatory audits.

We provide our services to

Manufacturing

Source Consulting provides assistance to contract manufacturers across the globe to ensure compliance with all regulatory requirements of their respective regulatory authorities. We also provide tools to enhance the standardisation of regulatory and quality systems to ensure product homogeneity.

Pharmaceuticals/ Bio- Pharmaceuticals

Both pharmaceutical and bio-pharmaceutical manufacturers face challenges in improving existing system and ensuring delivery of quality and products on a consistent basis. With the experience gained in the industry by our professionals believe in becoming part of the system before modifying it. Templates are prepared by professionals who worked on the shop floor for more than eight years. We recognize the complexity of GMP and accordingly we enforce change to ensure compliance.

Pharmaceutical and Biotechnology Start-ups

Regulatory bodies always encourage innovative ideas to realize the medical needs of patients by providing assistance in regulatory pathways like IND and NDA. Source Consulting provides support to start-ups engaged in innovating latest technology to help the consumers. We have solutions in place to implement quality requirements, compliance issues, vendor management and regulatory support so that companies have more time for research and development.