November 4, 2021
Have you heard of Good Machine Learning Practice (GMLP)?
Health Canada, the US Food & Drug Administration, and the UK’s Medicines & Healthcare products…
Regulatory & Quality Compliance consulting is pivotal for successful product development. It ensures compliance with regulations, preventing market entry barriers. AXSource delivers the ideal solution by seamlessly integrating regulatory expertise into new product strategies, ensuring market readiness and success.
Let us help you navigate the complex and ever-changing regulatory landscape
Our consultants are experts in navigating global requirements and can guide everything from CMC, regulatory, clinical, non-clinical, compliance, importation, licensing, labelling, and more. We have worked with clients all over the world, including start-ups, to large multinational organizations.
Our Leadership
Navneet Sekhon
President, AXSource Consulting Inc.
An accomplished management executive who has over 30 years of International Regulatory Affairs and Quality & Compliance expertise leading results-driven Project Management, strategic Clinical, Regulatory Affairs, QA/QC initiatives across diverse industries including Pharmaceuticals, Biologics, Natural Health Products, Medical Cannabis and Medical Devices within the R&D, non-clinical (GLP), clinical (GCP), manufacturing (GMP/MDSAP/ISO 13485), logistics/distribution (GDP), post-market (GVP) and medical sales & service environments.
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- Take Advantage of Our Years of Experience
- Expert Consultancy to Evaluate Your Product
- Reduce Your Risk
Take Advantage of Our Years of Experience
We provide Regulatory & Quality consulting services for many industries and have developed unequaled expertise in a range of therapeutic fields and product types. Our perspective is that of an independent partner to help you succeed – not as an outsider with a conflicting agenda.
Expert Consultancy to Evaluate Your Product
AXSource’s Regulatory & Quality Consulting offers specialized expertise to meticulously evaluate your product. We delve into the scientific and regulatory dimensions, providing insightful assessments to guide your development journey with informed recommendations.
Reduce Your Risk
Ensuring compliance is not just a choice but a necessity. Elevate your regulatory strategy with meticulous gap analysis and audits by our Regulatory & Quality Consulting. We mitigate your risk of non-compliance and ensure adherence to legal standards.
Industries We Serve
Active Pharmaceutical Ingredients (APIs)
Pharmaceutical & Biologics
Medical Devices & Diagnostics
Cosmetics
NHPs & OTC Drugs
Cannabis
Dedicated Industry Solutions
30
Years
of proven regulatory expertise
350
Clients
evolved their marketing & compliance Strategies
15
Countries
served with
Partner with us
AXSource is a life sciences consulting company providing expertise in regulatory & quality compliance services and we are looking for partners like you. Our goal is to grow together. We will support your business objectives while assisting our clients to leap ahead and succeed in their business ventures. Our strategic partners support our clients in business forecasting, sales and marketing, market access, translation services, digital transformation systems, third party logistics, pre-clinical & clinical studies and much more. If you are a life sciences business and you wish to participate, lets talk!
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FAQs on Regulatory & Quality Compliance
1. What is regulatory compliance consulting?
Regulatory compliance consulting involves helping businesses understand and adhere to laws, regulations, and standards relevant to their industry. This ensures that companies operate within legal boundaries and avoid penalties.
2. Why is regulatory compliance important?
Regulatory compliance is crucial for avoiding legal issues, fines, and reputational damage. It ensures that businesses meet industry standards, protect consumer safety, and maintain trust with stakeholders.
3. What is quality compliance consulting?
Quality compliance consulting focuses on ensuring that products and services meet defined quality standards. This involves implementing quality management systems, conducting audits, and continuous improvement initiatives to maintain high-quality outputs.
4. What are the benefits of hiring a compliance consultant?
Compliance consultants provide expertise in navigating complex regulations, identifying compliance gaps, and implementing effective strategies. Benefits include:
- Reduced risk of non-compliance
- Improved operational efficiency
- Enhanced product and service quality
- Better preparedness for audits and inspections
5. What industries benefit from regulatory and quality compliance consulting?
Industries such as pharmaceuticals, healthcare, manufacturing, finance, and technology benefit significantly from compliance consulting due to stringent regulatory requirements and the need for high-quality standards.
6. How do compliance consultants help with regulatory changes?
Compliance consultants stay updated with regulatory changes and help businesses adapt by revising policies, procedures, and training programs. This proactive approach ensures ongoing compliance and minimizes disruption.
7. What is the difference between quality assurance and compliance?
Quality assurance (QA) focuses on preventing defects and ensuring products meet quality standards through systematic processes. Compliance ensures adherence to legal and regulatory requirements. While QA aims at product quality, compliance ensures legal conformity.
8. How can a business assess its compliance needs?
A business can assess its compliance needs by conducting a compliance audit, reviewing current policies and procedures, and identifying areas of risk. Engaging a compliance consultant can provide a thorough assessment and tailored recommendations.
9. What are common challenges in maintaining compliance?
Common challenges include keeping up with regulatory changes, managing documentation, ensuring employee training, and integrating compliance into daily operations. Effective compliance management requires continuous monitoring and adaptation.
