RegulatoryPro provides global strategic and tactical guidance to R&D and Clinical Affairs management relating to statutory and regulatory requirements for the development and commercialization of drug, biologics and medical device products and processes.  Specific strategic advice and services include:

• Reliable, cost-effective approaches toward compliance with Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) requirements

• Addressing administrative procedures

• Preparing for manufacturing facility inspections

• Conducting product recalls and market withdrawal activities

• Compliant product reconditioning plans

• Responding to Agency warning letters

• Import/Export issues; proceedings relating to the refusal to admit importation or exportation of FDA-regulated products.

• Designing broad-based strategy for positioning investigational new products for human clinical trials (IND) and marketing approval (NDA, MAA, CTD)

• Conducting program review non-clinical (pharamcology & toxicology) to ensure study protocols and results generated provide scientific and regulatory support for subsequent clinical trials 

• CMC planning and manufacturing facility qualification or validation coordination to ensure processes and facilities meet minimum regulatory and statutory requirements

• Establishing and cultivating contacts with regulatory and other governmental agencies in the U.S. (FDA/CBER, CDER and CDRH, Ombudsman, and ORA) and various European Union countries to achieve corporate regulatory objectives.  RegulatoryPro's staff have negotiated directly and successfully with regulatory authorities in the U.S., Canada, U.K., Belgium, Germany, The Netherlands and Italy. 

• Drafting and/or reviewing clinical investigation plans, clinical protocols, case report forms, subject informed consent forms, investigator brochures, and site initiation documentation in support of proposed and active clinical trials.

• Provide project management services from research to development and ultimately regulatory approval.

We also advise clients concerning international regulatory developments, particularly those related to the European Union and Japan.  We devise appropriate regulatory plans to facilitate the submission of timely product registrations applications and ultimately gain marketing approval.