Launch Your Pharmaceutical Product

Reg-Tec exists to support your development process.

CLINICAL TRIAL MANAGEMENT

  • Strategic planning for new product development
  • 30 years in global product development for pharmaceutical companies
  • Regulatory feasibility review
  • NDA, 505(b)(2), and ANDA regulatory submissions
  • Assist with post-marketing responsibilities

MEDICAL DEVICE DEVELOPMENT

  • Set up & manage ANDA, 505(b)(2) NDA studies
  • Clinical site monitoring
  • GMP, CGC & GLP audits
  • Provide clinical and BA/BE study management

SERVICES

REGULATORY AFFAIRS

Strategic planning for new product development 30 years in global product development for pharmaceutical companies​.  Regulatory feasibility review​, NDA, 505(b)(2), and ANDA regulatory submissions.

PROJECT MANAGEMENT

Set up & manage ANDA,​ 505(b)(2) NDA studiesClinical site monitoringGMP, CGC & GLP audits.  ​Provide clinical and BA/BE study management.  Preparation of regulatory submissions & FDA liaison.

CLINICAL TRIAL MANAGEMENT

Meet ICH Guidance E6 Good Clinical Practice Guidance for the sponsor to ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s). This includes identification of appropriate CRO, bid defense, document review, sponsor audits, report reviews, etc.  Good for companies with no clinical departments or limited bandwidth or ex-US companies performing trials in the US.  Includes clinical endpoint studies and bio-equivalence studies.

EXPERTS FOR YOUR PHARMACEUTICAL DEVELOPMENT MANAGEMENT

Reg-Tec provides regulatory consulting and clinical management services to pharmaceutical companies that require assistance in the development of branded and generic products.

REGULATORY STRATEGY

PRODUCT ACQUISITION

PRODUCT LICENSING

Reg-Tec Pharmaceutical Presentation

PROJECT MANAGEMENT

CLINICAL TRIAL MANAGEMENT

CONTRACT NEGOTIATION

CONTACT REG-TEC
Office: 228 N. Front St.
Suite 302A
Wilmington, NC 28401
Mail: 8209 Market St.
Unit A, #268
Wilmington, NC 28411
(910) 550-0446

PHONE

(910) 550-0446

E-MAIL

masaikman@reg-tec.com

SOCIALS

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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