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:
- Active Pharmaceutical Ingredient (API)
- Intra Company Auditing
- Data Integrity
- Contract Manufacturing Organisation (CMO) audit
- Gap Analysis
- Pre-inspection preparation (MHRA/FDA/EMA/ANVISA/ISO)
- GMP/GDP
- Remediation activity auditing
- Packaging
- Medical Devices
- 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).
- 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.
Advantages
- Cost-effective
- End-to-end Regulatory consultation
- Qualified team of experts with hands-on experience across all categories of personal care and cosmetic products like Skincare, Oralcare, Hair care, Baby care and beauty products.
- Expert support for region-specific Regulatory complexities
- Interactions with Health Authorities (HAs)
- Structured approach to ensure quick product launch or market access
