Good Manufacturing Practices (GMP & GxP's)
cGMP Compliance
UnseenDots offers extensive services in GxP systems establishment and compliances to make your organization risk free from the regulatory actions.
We have capabilities and expertise to perform complete gap assessment against the various cGMP requirements and/or best industrial practices.
We assure to provide customised and easy to implement GMP compliant solutions along with necessary handholding and culture build-up support.
Our cGxP service offerings are below (but not limited to):
- GMP system development and establishment for new and ongoing facilities.
- Systems Audits, Gap assessment, providing recommendations, training and handholding services to achieve sustainable GxP compliance.
- Support on various types of investigations (complaints, Incidents & deviation, out of specifications (OOS), Root cause analysis (RCA) and Corrective & Preventive actions (CAPA) implementation.
- Prevent/minimize the cost of poor quality (COPQ).
- Quality risk assessment and mitigation plan.
- Data integrity and ALCOA++ (gap assessment, training and culture building support).
- Partnering to inculcate quality culture and drive cultural transformation.
- Onsite support at your premise as and when needed specially before, during or after audits or during execution of validation or other activities.
- Finally, assessing and providing support on digitalization initiatives and Computer systems validation.
Mock regulatory audit /Audit responses/ Remediation support for Pharmaceutical Industries
Team UnseenDots have knowledge, experience, and competencies in understanding the regulatory requirements. Our consultants are proficient to conduct mock regulatory audits as per the requirements of various international regulatory agencies.
Our services and offering are to help organizations to implement systems and processes, to remain GMP compliant. We also help to navigate inspections from USFDA, EDQM, EUGMP, MHRA, WHO and other global agencies etc.
Our domain experts will conduct onsite and/or remote audits and guide your organization on various GMP/GxP requirements and gaps.
Experts of UnseenDots will provide gap analysis, support to develop and implement effective corrective action plans before the actual audit.
Our team is also equipped to perform regular document review and electronic document review for assurance of your organization.
Our team has expertise to guide and prepare corrective actions response against the regulatory observations like USFDA 483’s.
If there are audit findings leading to adverse regulatory actions such as OAI, warning letters, show cause notices etc., our experts are there to evaluate and identify remedial actions for your organization.
Our experts will support in detailed investigation, assessment, planning, responding and execution of remediation actions to address deficiencies.