Recently Published Interview

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REGULA INSPECTION SERVICES INTERVIEW

Regula Inspection Services is a young company that aims to provide high quality, technically reliable and high value added inspection services especially for Pharmaceutical, Biotechnology, Medical Device Manufacturers and Suppliers. Deniz Edik is one of the founders of the company and has a reasonable background in Pharmaceuticals.

She is an expert who has worked in various departments for multinational and local Pharmaceutical companies and suppliers for many years. Deniz Hanım, who we believe will be one of the successful Women Entrepreneurs in our country, says that she aimed to establish her company which is composed of experts with sector experience to reach a wider audience. We talked with her about her company and services.

WINALLY: Have a nice day Mrs. Edik, Regula Inspection Services made a very fast introduction to Pharmaceuticals, Biotechnology and Medical Device sectors. Could you tell us about Regula Inspection Services?

RIS– Hello. Regula Inspection Services was established in order to provide Auditing Consultancy Services to Biotechnology, Medical Device sectors, mainly Pharmaceuticals. All of the GMP Auditors in the RIS team are IRCA-Certificated Lead Auditors who have worked as Lead Auditors and Managers in the Pharmaceutical Industry for many years.

WINALLY: What was your goal when establishing Regula Inspection Services and what kind of a return do you expect?

RIS: As we know, GMP (Good Manufacturing Practices) is a comprehensive set of systems consisting of an extremely strict set of rules which the Pharmaceutical, Biotechnology and Medical Device Industries must comply with. Turkish Medicines and Medical Device Agency (TMMDA) which was approved as a new member at the end of 2017 officially by PIC / S   mentions the importance of GMP inspection clearly in the manual.  These audits may be internal audits in which the firm controls its own Quality Management System and GMP Compliance as well as auditing of Active Pharmaceutical Ingredient, Excipient and Packaging Material Manufacurers and Suppliers according to Local and International rules. Readers can easily reach to TMMDA’s latest directive on GMP to get a detailed information of how to apply those rules to their operations. This very critical directive will be effective as of October 21st 2018. Read more

Do you know what to do with a FDA Warning Letter?

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We are at your disposal to interpret this warning letter and guide you all the way through the process. In this letter FDA declares that it has identified several violations and recommends you strongly engaging a consultant qualified as set forth 21 CFR Part 211 to assist your firm in meeting cGMP requirements. Read more

Join Our Growing Team

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Regula is seeking highly competent and experienced GXP auditors for its growing team.

Job Summary:

The successful candidate will be responsible for preparing, conducting, reporting GXP related Audits such as API, Excipient, Packaging Material Manufacturer & Supplier, Sterile/ Non-Sterile Medicinal Product Manufacturing Facilities, Data Integrity, Good Distribution Practices & Good Storage Practices according to Local and International Guidelines and Directives (FDA, EMA, MHRA, PIC/S, ICH, TMMDA etc.)

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