Pharmaceutical, Biotechnology, Genomics, Chemical, Medical Device, or supply chain management companies must adhere to strict quality, safety, and regulatory criteria in each area where their products are distributed. The current trend is to harmonise quality and safety standards around the globe. Whether you’re a manufacturer or a supplier, your company’s quality standards are crucial to its growth, continuous progress, and customer happiness.
Maven’s Compliance and Validation Centre of Excellence (CoE) can assist you in this effort by providing professionally aided compliance audit services for pharmaceuticals, medical devices, and consumer healthcare industries, including cGMP (current good manufacturing practises), GCP (good clinical practise), GDP (good distribution practise), GLP (good laboratory practise), GxP Computer System Validation (CSV)and GPVP (good pharmaceutical governance practises).
Maven offers regulatory compliance services, which include assessing your needs and recommending changes to company procedures to ensure both customer pleasure and compliance. We provide audit (gap analysis) reports along with advised actions for corrective and preventive actions (CAPA) to avoid potential 483s and audit findings from regulators using our audit preparation and readiness methodologies.
Maven guarantees that all of your processes and products are aligned with applicable quality, information security, compliance, and regulatory requirements such as (but not limited to) the following through in-house and on-demand compliance best practises and Regulatory compliance management.
Maven performs around 700 preliminary checks across 18-19 GMP functional areas.
key services in Maven Auditing arsenal are, but not limited to:
Preparation & Facilitation of Halal & Kosher Audits
We make sure that all of your processes and products comply with quality, information security, compliance, and regulatory requirements, including (but not limited to) the following.
Current Good Manufacturing Practices (cGMP): Quality and Regulatory compliance
ISO 9001: 2015 Quality Management Systems Requirements
Food and Drug Administration of the United States (US FDA) Quality System Regulation (21 CFR 820).
Food and Drug Administration of the United States (US FDA) EU (2003/94/EC Part I, II, III): Current Good Manufacturing Practices for Finished Pharmaceuticals (21 CFR 211).
Commission of the European Union Volume 4 of EudraLex – Guidelines for Good Manufacturing Practices for Human and Veterinary Medical Products.
CE certification.
GMP recommendations from Health Canada’s Health Products and Food Branch Inspectorate.
Good Manufacturing Practices (GMP) for Medicinal Products, PIC/S Guide.
What are the GMPs for active pharmaceutical components according to the WHO?
Medical Devices Quality Management System (ISO 13485:2016).
Guidelines issued by the Saudi Food and Drug Authority (SFDA): GMP for Medicinal Products: A Guide
ICH guidelines applicable.
Good Laboratory Practice:
Guidelines for Good Laboratory Practice, OECD (Organization for Economic Co-operation and Development).
General Requirements for the Competence of Testing and Calibration Laboratories (ISO / IEC 17025: 2017).
21 CFR 58: Nonclinical Laboratory Studies – Good Laboratory Practice
In analytical procedures, the EURACHEM / CITAC Guide: Guide to Quality in Analytical Chemistry – An Aid to Accreditation, 3rd Edition (2016) should be followed.
Feb 2000, Guide to UK GLP Regulations (by GLPMA).
Nonclinical Laboratory Study: Finalized Guidance Document from Health Canada Information for Drug Product Applications and Submissions: GLP (Good Laboratory Practice) observance.
Quality practises for Regulated Non-Clinical Research and Development, according to the WHO Handbook on Good Laboratory Practice (GLP).
Occupational Safety and Health Administration (OSHA) regulations.
ICH guidelines applicable.
Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP)
Pharmacovigilance Planning from End to End.
E6 is an ICH Harmonised Tripartite Guideline for Good Clinical Practice.
Post-Market Non-Expedited ICSRs Technical Questions and Answers – Providing Submissions in Electronic Format
Requirements for FDA Safety Reporting for INDs and BA/BE Studies
Specification and related files for the E2B(R3) Individual Case Safety Report (ICSR).
ICH E2B(R3) Reporting to the FDA Adverse Event Reporting System: FDA Regional Implementation Specifications (FAERS).
Other ICH guidelines that apply.
Human Drug and Biological Product Post-Marketing Safety Reporting, Including Vaccines.
Modules on guidelines for good pharmacovigilance practises (GVP).
Information Security, Data Privacy and Computer System Validation (CSV)
Information Technology – Security Techniques – Information Security Management System – Requirements (ISO 27001:2013).
ISO 27002: 2013 Information Technology – Security Techniques – Code of Practice for Information Security Management is a code of practise for information security management.
USFDA 21 CFR Part 11: Electronic Records; Electronic Signatures – Scope and Application
EU GMP guide Annex 11
Japanese ERES Guideline Notification No 0401022
GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems
USFDA – Software Validation Guidelines
Applicable ICH QSEM guidelines
About Us
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.