Reg-Tec Consultants

Reg-Tec, Inc. reaches out to a team of experts for close collaboration, assembling a strong consulting team to address your pharmaceutical concerns

Clinical Project Management Team

Our consultant manages clinical BE and dermatology studies; manages in vivo work for various CRO's; extensive experience monitoring studies, as well as reviewing reports, protocols, and ANDA filings.

Senior clinical stage research professional with over twenty-five years’ experience in global clinical research, program management, and operations. A breadth of experience and proven track record of success encompassing various products, phases, and multiple therapeutic areas.  Areas of specialization: Complex Global Project Management, Financial/Budget/Contract Management; Outsourcing Strategies {CRO and FSP(Lab/EDC/IVRS/CTMS/IRB)};
Compliance/Risk Management, Stakeholder/Cross-Functional Integration, Resource Optimization, Patient and Employee Engagement; Executive/Client Advisor, Strategic Initiative Implementation, Strategic Research Design Phase 1- 4, Global Regulatory Compliance; Team Training/Development,-e-clinical Trial Operations, Modernization.



Regulatory

Our consultant has pharmaceutical experience in pre-IND packages and meetings, IND's, 505(b)(2) NDA's, ANDA's and 510(k)'s and as a past FDA Review Chemist, our consultant coordinates and prepares regulatory submissions; manages final product submissions and negotiates and communicates with regulatory authorities.

Regulatory Affairs Professional with 25+ years of pharmaceutical industry experience including 23 years in Regulatory Affairs Chemistry, Manufacturing, and Control (CMC) and 4 years in management. 

Results-oriented, hands-on professional with a successful record of accomplishments in small molecule global regulatory CMC submissions (including ANDAs, NDAs, IND/CTAs, annual reports), project management, change control, labeling, controlled substances, and adverse event complaint reporting. Thorough knowledge of FDA cGMP, Code of Federal Regulations, global CMC clinical trial requirements, FDA/EU Guidelines and Directives, ICH requirements.

Biostatistics Team

The consultant has 40 years experience in the pharmaceutical industry, registering and cataloging the results of various clinical tests; designs and analyzes pilot and pivotal bioavailability/bioequivalence studies; assists in the design and analysis of studies with clinical and/or pharmacodynamic endpoints; interprets results of in-vivo studies to guide formulation development. He provides general PK, statistical and clinical consultation for ANDA and NDA 505(b)(2) projects.

Provides statistical consulting and statistical programming services to the pharmaceutical industry; the consultant has experience working with large and small contract research organizations and large, mid-size, and small pharmaceutical companies.

With extensive experience in all phases of drug development and numerous regulatory submissions across various indications, the company is positioned to provide strong statistical consulting and programming support utilizing sound scientific reasoning and the latest computing technology.

GCP, GLP, GMP AUDITING

The consultant has relevant experience which includes over 450 QA-GCP, GCLP, GDP, CMC, PVG, QC, domestic and international audits of clinical investigator sites, CROs, sponsors, and vendors. Additional experience in inspection readiness and hosting inspections, team/trials management, sponsor, CRO, Investigator Site, SMO, and vendor quality assurance, oversight, strategic planning, and SME. Over twenty years of clinical trials experience in site coordination/management, monitoring, and audits.
Reg-Tec provides regulatory consulting and clinical management services to pharmaceutical companies that require assistance in the development of branded and generic products.
msaikman@reg-tec.com
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