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)
