Regulatory Consulting
MAVEN specializes in supporting different industries with distributed and de-centralized Regulatory departments to come up with a more centralized Regulatory consulting model. We help you design a Centralization Program and support in implementing centralization of the following key Regulatory functions
Regulatory Consultation
- Pre IND and NDA meetings
- Pharmaceutical and Biologics Registration
- Medical device testing , MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER)
- Electrical and Electronics products testing , technical file , Declaration of Conformity
- Textile products care labeling , packaging, fire resistant testing, Fiber Content Labelling and Marking
- EU REACH Registration, TSCA certification , GHS SDS and Labeling, Chemical Regulation Compliance
- Children’s products, Toys safety testing and hazardous labeling and marking
Toxicological and Clinical Consultation
- Toxicology Risk Assessment Report and Exposure Calculations to determine Margin of Safety (MoS)
- Safety Data Sheet (SDS) Authoring Services as per GHS standard format
- CPSR as per Europe regulation 1223/2009 (Part A & Part B)
- Post-Market Clinical Follow-up Studies (PMCF) for Medical Devices
- Clinical Trial Study Design, Investigator Boucher, Protocol Development and Clinical Study Report (CSR)
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.
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.
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