GMP
Quality Compliance provides comprehensive, innovative and hands-on GMP services to the bio pharmaceutical and medical device space to ensure regulatory compliance and sustainability. Our team of seasoned and knowledgeable US-based consultants augmented by Indian pharmaceutical professionals, can design and implement a plan based on your company’s specific needs and requirements. Strong project management to determine root cause of the issues and a holistic plan to bring your company back on track provides value for your investment.
Validation
Hands-on approach to assist clients in establishing a validation master plan to be able to navigate to the various aspect of validation and qualification throughout the product life cycle, applying the common core of quality assurance and compliance principles. Highly-trained and experienced consultants develop and execute validation protocols in accordance with regulatory requirements and best in industry practices.
Facilities, Equipment and Utilities Qualification, Aseptic & Sterilization Validation, Cleaning and Contamination Control, Technology Transfer, Product and Process Validation, Method Validation and Computer Systems Validation (CSV)
Remediation
Compliance with regulatory agencies is the primary goal of our compliance and remediation services, to maintain and elevate the client’s quality system ensuring conformance and sustainability
Proactively design and implement measures, including routine
QMS and supplier audits to increase robustness.
Quality Compliance in collaboration with the client to implement lasting change to remediate regulatory infractions by assembling multi-discipline team to assess and provide customized remediation plan.
Auditing and Due Diligence
We conducts audits for the clients in order to ensure compliance and to stay ahead of the curve required to remain audit-ready at all times. Perform mock audits based on the methodologies by major regulatory agencies, issue a report in competent authority format and assist in responding
to the observations.Inspection readiness training, covering inspection management, back room logistics, respondent training and mock inspection to prepare your facilities and team for inspection.Inspection response assistance in managing response to inspection report received from regulatory agency audit and inspection including drafting reports, assisting with problem solving, system re-design, and training. Vendor Audits to ensure that client vendors are compliant with the relevant standards.
Agile Transformation
A group of like-minded people who have deep experience in the transformation and training industry have come together to form this organization to fill the lacuna in the industry where there are several training and transformation services providers, but the attention to the exact context of the customers to increase the effectiveness of the training and transformation, is missing. Our target customers are the people and organizations who are at a tipping point in their journey and ready to unlearn and learn new ways to transform and become agile
We use Agile, SAFe, Kanban, Scrum and Design Thinking as the tools to help in the transformation. SAFe talent augmentation, short and long-term resource enablement is our expertise.
Digital Transformation
With our deep expertise in technology solutions, we help our clients navigate today’s demanding digital world through Software Development Outsourcing, Mobile & web solutions, Testing & Quality Assurance, Application Development, Cloud infrastructure & hosting, Robotics Process Automation (RPA), Open banking with API, Kondor Trade Processing, Data Science and Engineering, Digital Structure, Marketing Analytics and Cyber Security Services.
Talent Augmentation / Recruitment
The cornerstone of effective organization is efficient and productive employees. Invest in your primary asset to create a culture of growth, efficiency and productivity. Every company desires to always get better and surrounded by agile employees. We have experts in HR sales, consulting,assessment and training where goal to to hire,train and coach to create an
Coaching and Mentoring
Coaching and Mentoring experts facilitate coaching and mentoring experience at all the levels to bring clarity,focus and positive mindset. We collaborated with Coaches and Mentors around the world to help the organization at all the levels.