Regulatory Services

Delivering cost-effective solutions tailored to small, mid-sized, and large pharma companies

RCS offers expert navigation of the pharmaceutical and medical device regulatory landscapes across the Asia-Pacific region, including Australia, China, India, Japan, South Korea, and beyond. With strong connections to global regulatory bodies like the US FDA, EMA, and China’s CDE, our team ensures your project meets the latest standards.

We specialise in identifying and documenting the critical data needed for successful NDAs, IND filings, and BLAs, providing tailored strategies to streamline the regulatory process and accelerate your market access.

16+ years of Proven Experience
Global Regulatory Staff
Support a variety of submissions
End to End Regulatory strategy
24 hour support, practical guidance and complete technical assistance

Key Highlights

Medical Device

Registration
Import License
Manufacturing License
ISO 14155 and QMS etc.

Drugs

New Drug Approval
Subsequent New Drug Approval
Test Licenses
Post Approval Changes
BE NOC, etc.

IVD

Registration
Import License
Manufacturing License
Performance Evaluation

Nutraceuticals

FSSAI License or Registration
Compliance
Claim Approval
Non-Specified Food Compliance
Function Foods approvals and compliance

Biologics

Registration of biologicals
Import license
Test license
Export NOC
CLAA, LVP, Serums, NOC for Vaccines, etc.

Cosmetics

Cosmetic registration and approval
Labeling assistance,
Testing
Cosmetic Product Compliance etc.

Global Regulatory Services

Our comprehensive regulatory affairs solutions support the full product life cycle and all product groups, including small molecules, biologicals, biosimilars, vaccines, medical devices etc.

Why Choose RCS

Expertise Across Regions
Strong Global Connections
Full-spectrum regulatory services
Cost-Effective Approach
Proactive identification and mitigation of regulatory risks
Dedicated team of regulatory experts

Contact us today to learn more about how RCS can support your regulatory and compliance needs