Maven Regulatory Solutions
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. Maven operates in the life science industry often deals with more challenging medical products. Due to drastic technology changes regulations are unable to keep up with the updates, invariably more products tend to reject. Therefore we have bought in teams of specialists who have both scientific skills and regulatory expertise with their ability to communicate and co-ordinate effectively with the regulatory bodies to achieve the very best outcome for our clients.
Our Vision
To be the preeminent leader in toxicology and regulatory services, driving advancements that ensure the safety and compliance of products worldwide. Our vision is to navigate the complex regulatory landscape with unparalleled expertise, fostering innovation and delivering solutions that contribute to a safer, healthier, and more sustainable global environment. As a trusted partner, we aspire to redefine industry standards and empower clients to achieve regulatory excellence.
Our Mission
Our mission is to safeguard public health and support the success of our clients by providing cutting-edge toxicology and regulatory services. We are committed to conducting thorough and reliable assessments, ensuring that products meet stringent safety standards and comply with regulatory requirements. Through our expertise, transparency, and dedication to excellence, we aim to facilitate the regulatory approval process, enabling clients to bring safe and compliant products to market efficiently. Our mission is to be a trusted partner in advancing public health and regulatory success
Quality Policy
At Maven Regulatory Solutions, we are dedicated to providing premier toxicology and regulatory services that consistently meet or exceed the expectations of our clients and regulatory authorities. Our commitment to quality is embedded in every aspect of our operations, ensuring the safety, efficacy, and compliance of the products we support.
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REPORTS
USA | UK | CANADA | GERMANY | FRANCE | SPAIN | SWEDEN | FINLAND | AUSTRALIA
SOUTH AFRICA | BRAZIL | PERU | ISRAEL | UAE | SAUDI ARABIA | TURKEY | QATAR | BAHRAIN
INDIA | CHINA | SINGAPORE | MALASIYA | NEW ZEALAND | KUWAIT | BANGLADESH
Services offered
Toxicology reports Like PDE, OEL, Nitrosamines analysis, Q(s)AR, Organic and Elemental Impurities.
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New product and market Submissions to HA’s, Regulatory Intelligence, Regulatory Information, Reporting and Analytics.
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We provide innovative & cost-effective operational quality services to tackle Small and Mid-size Pharma Industry challenges.
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HClinical summaries (eCTD Module 2.7), Gap analysis, Clinical and Non-Clinical document, Strategic support.
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GxP auditing, Consulting, QMS remediation, process and product validation, Life Sciences companies.
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For all of your biostatistics, statistical programming, and data management needs.
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Maven assists you with literature review, economic modelling, real world evidence.
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Industries
Medical Devices
MD classification, compiling Device documentation, Medical Writing, Device Registration and acting as an in-country representative. We customize the process with respect to service and software assistance for end-to-end device approvals.
Pharmaceuticals
Maven expertise to handle the different phases of Drug, Vaccines and Biosimilar registration, from development to dossier Gap Analysis, Preparation and Submission to Lifecycle management.
Cosmetics
Expertise in global regulations like EU directive 1223/2009, US regulations US FDA CFR Title 21 part 700 to 740, Canada Cosmetic regulations, ASEAN Cosmetic Directive (ACD) and GCC GSO standards.
Food Supplements & Nutraceuticals
MAVEN will provide product compliance, label assessment, claims review, product classification, registration and market continuity according to global Regulatory compliance requirements.
Chemicals
Maven specialises in CSRA practise in the areas of EU REACH and CLP Registration/Dossier Updates, Hazard Communication (Safety Data Sheet/ Label) Development/ Review/Updates, and Raw Materials Document Management System (RM-DMS).
Veterinary
Maven provides toxicological analyses for food and feed additives. This primarily relates to feed for farmed livestock, but it also includes feed for horses, pets, farmed fish, zoo and circus animals, and wild animals.
NEWS
Maven´s 360º approach to the Life Sciences
- The SFDA's General Product Claim Rules.
- The PMDA responds to questions about Japan's drug master file regulations.
- TGA Establishes COVID-19 Testing Software Regulatory Requirements.
- The FDA's Guidance Addresses Repeatedly Requested CMC Questions for Generic Drugs.
- FDA Completes More Biosimilar Development Q&As.
