Driving compliance, uncompromising quality, and accelerated global approvals for your Pharmaceutical products portfolio.
Meet our founders with 12+ years of proven expertise in Pharma regulatory affairs and analytical R&D across global pharmaceutical markets
Founder
12 years of proven expertise in API regulatory affairs across global markets
Founder
12 years of expertise in analytical R&D, method development and validation from raw materials to API
End-to-end regulatory services tailored for Pharmaceutical Products
We specialize in strategic market entry planning across the globe.
Complete regulatory lifecycle management from initial submission through post-approval maintenance and variations.
Expert guidance on regulatory pathways, submission strategies, and market-specific requirements to accelerate your approvals.
Proactive compliance assessments, deficiency resolution, and comprehensive audit support services w.r.t DMF/Dossier submissions.
Comprehensive regulatory documentation and submission services
Complete preparation, submission, and ongoing maintenance of Drug Master Files/Dossier for global markets.
Suggestion on required documents for the preparation and submission of DMF/Dossier for Global market access.
Expert in handling of eCTD and non-eCTD submission formats to meet regional requirements.
Minimize approval delays with our strategic approach to handling regulatory deficiency responses.
Strategic management of post-approval variations and regulatory change notifications.
Full compliance with ICH, FDA, EMA, and WHO guidelines across all deliverables.
Comprehensive regulatory support across regulated and emerging markets worldwide
US FDA submissions and compliance
EMA and National Authorities submissions and compliance
UK MHRA submissions and compliance
Health Canada submissions and compliance
PMDA submissions and compliance
CDSCO submissions and compliance
ANVISA submissions and compliance
NMPA submissions and compliance
South Korea, ASEAN, LATAM, Africa, CIS etc.
Excellence in every aspect of regulatory service delivery
Experienced professionals with extensive global regulatory exposure and deep API & Finished product sector knowledge.
Customised regulatory strategies tailored to your specific products and target markets.
Unwavering commitment to accuracy, compliance, and meeting critical timelines.
Competitive pricing with global reach, delivering exceptional value for your investment.
Absolute protection of your proprietary information and data integrity.
Continuous regulatory updates and market insights to keep you ahead.
Building lasting relationships focused on your sustained regulatory success.
Full compliance with ICH, FDA, EMA, and WHO guidelines across all deliverables.
To become the most trusted global regulatory partner for API & Finished products manufacturers worldwide, delivering excellence and reliability in every market we serve.
To provide accurate, compliant, and cost-effective regulatory solutions that enable our clients to achieve faster approvals and sustainable compliance across all global markets.
Contact MGRS today to discuss how we can support your market access goals
Miyapur, Hyderabad
Telangana, India
+91 99081 80130
+91 97030 47971