Experienced and expert GMP, GDP auditors in Regula Inspection Services provide independent audit services for Contract Manufacturing and Laboratories, API Suppliers & Manufacturers, Excipient Suppliers & Manufacturers, Primary & Secondary Packaging Material Suppliers & Manufacturers and 3rd Party Logistic Service Providers. Our first and foremost duty is to assess and perform audits without any conflict of interest with an entirely objective and independent perspective as per current guidelines and regulations by Certificated and Competent Lead Auditor and Auditors.
By recognizing what integrated supply chain means for our customers and always prioritizing it as the most important initiative, we use the current and valid guidelines in order to audit Active Pharmaceutical Ingredient (API) Manufacturers and Suppliers. Our GMP auditors who have Lead Auditor Certificates have an extensive knowledge and competence in API Audits.
Data integrity problems affect Pharmaceutical, Biotechnology and Medical Device companies.
Due to the complexity of the data environment, Data Integrity audit is a critical and challenging process. Since Data Integrity must be assessed from a deep and broad perspective, there are a number of criteria that auditors have to examine. There is a possibility that the uneducated and inexperienced Auditor will cause much harm when performed DI audits with wrong methods and approaches. With Data Integrity Audits, you can meet healthcare providers’ expectations and needs and also make your processes more secure, efficient, and productive. The Data Integrity concept is one of the most discussed agenda items in the Pharmaceutical, Biotechnology, Medical Device Industries.
By recognizing what integrated supply chain means for our customers and always prioritizing it as the most important initiative, we use the guidelines from several International regulatory authorities.
Experienced consultants and auditors of Regula Inspection Services offer solutions by sharing their expertise with you to prepare the necessary responses of the findings detected by International and Local Authority Inspections.
Preparing a response to 483
Preparing a response to Warning Letter
Determining Root Causes
Planning and implementation of Corrective & Preventive Actions
Preparation of remediation and action plans according to the categories of Critical, Major, Minor findings.
We are at your service with the most suitable preparation methods for Healthcare Authority Inspections.
Our experts in our audit team have many years of experience in Local and International audits. We guarantee that preparatory phase will be highly productive with the aid of experienced and competent auditors who have unique insight into audits, questions and responses. With our Inspection Readiness service we are revealing your strengths, weaknesses.
Local and International Audits;
FDA audit preparation
FDA pre-approval inspection preparation
EU / EMA audit preparation
MHRA audit preparation
TMMDA audit preparation
Ministry of Agriculture and Forestry GMP audit preparation
PIC / S audit preparation
WHO audit preparation
TGA audit preparation
INAME audit preparation
ANSM audit preparation
ZLG audit preparation
PMDA audit preparation
Inspections are challenging processes that need to be taken seriously by the Pharmaceutical, Biotechnology, Medical Device Industries.
Nonconformities obtained by the organizations as a result of the audit may result in irrecoverable situations. Top Management who are aware of the results of the nonconformity caused by the audit results want to know in advance where the possible problems are. For this reason, it chooses to perform a detailed Mock Regulatory Inspection by an Independent and Specialized Company. As a result, the top management of the company takes precautions by anticipating the weak points and gaps in the processes.
Our Mock Regulatory Inspection and Gap Analysis service is finalized with a detailed report at the end of 5 days.
Overall Evaluation and Conclusion
With the application of Mock Regulatory Inspection & Gap Analysis, top management can obtain all the weaknesses of the facility very fast.
It sees the problems in advance that are likely to be encountered in the actual audits of the institutions such as FDA, MHRA, PIC / S, TMMDA etc. and ensures that action is taken for their solution.