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