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Our dedicated regulatory experts collaborate closely with you to address your specific needs
"Navigate the ever-changing regulatory landscape with confidence, guided by our Pharma Regulatory Services team. We offer expert support to help you successfully manage the complexities of the evolving regulatory environment."
Markets Catered
- USA: NDA, NCE, ANDA, USDMF
- Europe: CP, DCP, MRP, National, CEP
- India: DCGI, CDSCO
- Canada: Health Canada
- Australia: TGA
- Brazil: ANVISA/REBLAS
- China: NMPA
- Rest of the World (ROW)
Regulatory Services
- Product Development and Registration
- Compliance and Risk Management
- Supporting regulatory biowaiver submissions
- Submissions and Approvals
- Post-Marketing Surveillance and Vigilance
- Regulatory Strategy and Consulting
- Lifecycle Management
- Agency Deficiency Response
- Due Diligence Support: Assisting in regulatory assessments during mergers and acquisitions
- Training and Webinars: Offering informational and educational resources to your team
Quality Services
- Qualification: Ensuring equipment, vendor, facility and processes meet all regulatory standards.
- Validation Planning and Compliance: Developing and implementing validation strategies.
- Risk Management: Identifying and mitigating potential risks.
- Technology Transfer: Facilitating seamless technology transfer.
- Documentation Support: PDR, DDR, MDR, Stability Reports Other protocol based studies.
- Audit support: Site audit and query compliance support.
Innovative Approach
Personalized Support
Proactive Guidance
We stay ahead of regulatory changes, ensuring you're always informed and prepared.
Integrated Solutions
Our services are designed to work together seamlessly, streamlining your regulatory journey.
Regulatory Expertise
Global Knowledge
In-depth understanding of regulations and guidelines worldwid
Agency Experience
Extensive interaction with FDA, EMA, ANVISA, NMPA, and other key regulatory bodies.
Industry Insight
Awareness of current trends and emerging issues in the regulatory landscape.
Success Stories
- Case Study 1:
Successful ANVISA filings led to early market entry for ten pharmaceutical companies in Brazil.
- Case Study 2:
Implemented global regulatory compliance strategy for a pharmaceutical company, ensuring smooth market access into Brazil, Europe, USA and ROW countries.
Why Choose Us?
Expertise
Our team possesses decades of combined regulatory experience.
Innovation
We leverage technology and creative thinking to deliver tailored solutions.
Partnership
We work closely with you to understand and achieve your goals.
Infrastructure
With the support of our state-of-the-art formulation and analytical lab, we offer a one-stop solution for all your regulatory filings.