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Counseling and mentoring by EKR Santé is custom-tailored based on the needs of each client.

Approach

EKR Santé proposes consulting services in Quality Management and Regulatory Compliance to members of the pharmaceutical, medical device, cosmetics industries and for other healthcare products (natural health products, dietary supplements, etc.).

EKR Santé uses mainly, and aims at integrating in its client’s processes, risk-based and Quality-by-design approaches, in order to allow companies to focus their quality management resources on critical points affecting the quality of products and the safety of patients and users.

Through an approach based on evaluation, cooperation and training, EKR Santé assists each company and manages each project in order to ensure and optimize the transfer of tools and expertise to the company’s personnel.

Counseling and mentoring by EKR Santé is custom-tailored based on the needs of each client, the size of the company or the project, the type of products manufactured, the existing quality management systems, and the internal resources of each company.

About

Emmanuel Klem-Robin is a professional chemist with over 25 years professional experience. Following an early career as an analytical chemist in forensic sciences and the scientific police, Emmanuel integrated pharmaceutical laboratories in 1999. His expertise is based on 20 years of laboratory and consulting experience for dozens of companies in both North America and Europe, and notably in projects aimed at reaching and maintaining compliance with regulatory agencies regulations and requirements (EMA, ANSM, FDA, Health Canada) and applicable standards (ISO, CEN, AFNOR, ANSI, etc.).

This 10-years experience as an independent consultant and in partnership with other industry members, after over 7 years in an international consulting firm (Validapro Biosciences), focuses on the following activities:

EMA, FDA, ANSM & Health Canada Compliance
Development, implementation and management of Quality Systems, for pharmaceutical and medical device development and manufacturing
Gap analyses and inspection preparation
Compliance readiness and remediation plans
Suppliers and sub-contractors’ third-party audits
Transition management - Responsibility of QA positions
CMC and Technical Files
Development of risk management plans – Risk analyses
Development on Quality-by-design strategies
Process Control Improvement – Process Validation
Coaching and Training of teams

A list of projects and achievements is available upon request.

Partners

EKR Santé also offers access to other services in Validation, Engineering, Project Management and Regulatory Affairs through a network of partners covering all fields and expertise required by the pharmaceutical, medical devices and cosmetic industries as well as other health products (natural health products, dietary supplements).

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Through an approach based on process analysis, cooperation and training, EKR Santé assists each company and manages each project in order to ensure and optimize the transfer of tools and expertise to the company’s personnel.

Pharmaceuticals

Basis for regulatory and standards compliance	Applicable national and regional laws and regulations EMA, FDA, Health Canada Good Manufacturing Practices (cGMP) Health agencies and ICH guidelines Guidelines from other industry bodies and associations (ex: ISPE), Technical standards (ISO, CEN, ANSI, etc.) Risk management guidelines, ISO 31000, and associated tools
Compliance Project Management	Regulatory studies and analysis of regulatory requirements Gap analyses of quality systems and organizational structures Compliance reports and action plans Quality plans Development and implementation of Quality Systems and Processes Development and implementation of Standard Operating Procedures Project Management Feasibility studies – Logistical and technical analyses
Quality Assurance Management (Quality Control Officer functions)	Standard Operating Procedures (SOPs) Management of products specifications and CMC / regulatory files Product release (North America) Management of non-conformances, CAPA, complaints, adverse events, and recalls Self-inspections Supplier and sub-contractors third-party audits Quality agreements
Management of inspections from regulatory agencies and certification bodies	Preparation for inspections Assistance during inspections Management of response to regulatory agencies requests for modifications Follow-up action plans and implementation of modifications
Training	cGMP Quality Management Systems (QMS) Risk Management ISO standards ICH guidelines Validation Cross-contamination Auditing
Validation	Validation Master Plans (VMP) Process validation Analytical methods validation Cleaning validation
Risk management	Risk analyses (Products and Manufacturing Processes, Contamination management, QM Processes, etc.) Development of risk management systems
Regulatory Affairs	Liaison with regulatory agencies (FDA, ANSM, Health Canada) Establishment licences Preparation and review of regulatory dossiers / CMC (DMF, IMPD, NDA, ANDA, DIN, NPN) Support with product file preparation and licensing
Clients	Adhex Pharma, Lonza / Capsugel, Cenexi, , Mylan / MEDA, Bostik, Panpharma, Sandoz (Novartis), Patheon, Delpharm, IntelgenX, Schering Plough, Capsugel, Besins Healthcare, Merial, Vetoquinol, CEVA, Virbac, Cebiphar, MEDA, Ropack, Servier Canada, Imtix-SangStat, Pierre Fabre Médicament, Ipsen, Cephalon, DraxImage, Valeant, Mayne Pharma, Canderm, Genesis, Laboratoires Giroux (Galenova), TcL Pharma, L'Oréal, Duchesnay, Angiogène, CellMed, McNeil, Searchlight Pharma, Oral Science, Pharmascience

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EKR Santé also offers access to other services in Validation, Engineering, Project Management and Regulatory Affairs through a network of partners covering all fields and expertise required by the pharmaceutical, medical devices and natural health products industries.

Medical Devices

Bases	Applicable national and regional laws and regulations ISO 13485 QS, Quality Systems Regulations (FDA) Health agencies and IMDRF (former GHTF) guidelines Risk management standards (ISO 14971, ISO 31000), and associated tools Guidelines from other industry bodies and associations (ex: ISPE) Technical standards (ISO, CEN, ANSI, ASTM, etc.)
Compliance Project Management	Regulatory studies and analysis of regulatory requirements Gap analyses of quality systems and organizational structures Compliance reports and action plans Quality plans Development and implementation of Quality Systems and Processes Development and implementation of Standard Operating Procedures (SOPs) Project Management Feasibility studies – Logistical and technical analyses
Quality Assurance Management (Quality Control Officer functions)	Design Controls Standard Operating Procedures Management of products specifications and regulatory files Product release Management of non-conformances, CAPA, complaints, adverse events, recalls Self-inspections Supplier and sub-contractors third party audits Quality agreements
Management of inspections from regulatory agencies and certification bodies	Preparation for inspections Assistance during inspections Management of response to requests for modifications Follow-up action plans and implementation of modifications
Training	Design and Manufacturing Quality Management Systems (ISO, FDA) Design Controls and Risk Management Validation
Validation	Process Validation Design Validation V&V
Risk management	Design and manufacturing risk and criticality analyses Development of risk management systems
Regulatory Affairs	Liaison with regulatory agencies Liaison with notified bodies Establishment licences Support with product file preparation and licensing
Clients	Womed, Adhex Technologies, Adhex Pharma, Clemex, Johnson & Johnson, ArjoHuntleigh, GalMed (division of Galderma), Elekta, Oral Science, Searchlight Pharma, Hygie

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Emmanuel Robin, Consultant
EKR Santé
Qualité & Conformité / Quality & Compliance
+33 (0)7-68-84-52-30
www.ekrsante.ca
emmanuel@ekrsante.ca