Regulatory Services

Pharma regulatory affairs is an essential component of the pharmaceutical industry, as it ensures that all products meet safety and quality standards. Regulatory Affairs professionals are responsible for managing interactions between the company and relevant national or international health authorities in order to ensure compliance with applicable regulations. They also provide guidance on product development, marketing authorization applications, manufacturing processes, labeling requirements and post-marketing activities. As such they play a vital role in ensuring that medicines reach patients safely and effectively while protecting public health worlwide.

As regulations become more stringent, it is important to stay updated with these changes to ensure product approval. Partnering with subject matter expertise that bring experience and knowledge for regulated and emerging markets that drive regulatory activities with high-end technology ensures that pharmaceutical products reach the market in a timely manner. This minimizes risk to business and greater return of investments.

SZReg Pharma provides services in the area of GCC, EU, Canada, CIS, Africa and ROW market Regulatory Affairs. SZReg Pharma is reputed by its customers for delivering high-quality regulatory results to ensure that our customers’ products obtain rapid market access with 100% success rate. SZReg Pharma offers comprehensive and customized regulatory services. Our services in this specialized pharmaceutical area are included below:

  • Registration Strategy in Emerging Markets and European Union

  • Regulatory Feasibility Analysis

  • Product Filing and Variation strategies

  • Advisory on CMC data generation for successful filing

  • Change Control Strategies

  • Subject Matter Expertise

  • Query Responses strategies

  • Electronic Submission of medicinal products

  • Compiling, hosting and maintenance of eCTDs

  • Preparation of baseline submissions

  • Clinical trials consultation

  • Medical devices registration

  • Pharmacovigilance

  • Pricing and Market Research

  • Market Authorization Representation

  • Cosmetic Products Listing

  • Patent Information