"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: CADIFA/CBPF
- China: NMPA
- Rest of the World (ROW)
Regulatory Services
- Product Development and Registration
- Compliance and Risk Management
- 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 keep your team informed.
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.
Audit
Innovative Approach
- Personalized Support: Our dedicated regulatory experts collaborate closely with you to address your specific needs.
- 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 worldwide.
- 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.
