Regulatory Affairs Consultant

Specialized regulatory services across pharmaceuticals, medical devices, cosmetics, health foods, veterinary products, industrial and consumer goods.

Cisema is your trusted regulatory affairs consultant for China, Hong Kong, Taiwan, and Southeast Asia. With significant regulatory experience, we deliver customized regulatory strategy, authority communication, and full lifecycle management tailored to your product type and regulatory challenge. Whether launching drug applications, registering a medical device, or filing a cosmetic or health supplement, our regulatory affairs experts provide hands on support from submission to surveillance, ensuring successful market entry in key markets.

Medical device clinical trial in China img

Regulatory Intelligence

In today’s fast-paced regulatory landscape, we keep our clients ahead by delivering timely regulatory intelligence. We continuously monitor and analyze regulatory changes, updates, and trends from regulatory agencies and regulatory authorities not only in the jurisdictions we specialize in but also worldwide. With our deep understanding of both global regulatory requirements and local requirements, we provide actionable insights that help companies anticipate potential challenges, adapt strategies, and maintain compliance. By taking this proactive approach, we not only support the development of effective regulatory strategies but also maximize approval success and minimize costly delays, ensuring our clients maintain a competitive edge.

Pharmaceutical & Biotech Regulatory Services

The Asia Pacific region offers major opportunities for life sciences companies, but success requires more than global documentation. At Cisema, we provide tailored regulatory affairs consulting that combines regulatory intelligence, local expertise, and operational precision. From clinical trial applications to post-market lifecycle management, our experienced team reduces approval risks, ensures compliance with local requirements, and streamlines regulatory submissions to accelerate successful market entry across the region.

Regulatory Strategy & Planning

Regulatory classification and country-specific roadmap development

Local adaptation of global regulatory strategy

(Pre-) IND,s CTAs, (Pre-) NDAs, MAAs, BLAs, to DMF planning and submissions

Dossier Preparation & Submission Management

Full lifecycle document preparation and formatting

Submission management to NMPA and APAC authorities

Real-time engagement for regulatory submissions

CMC & GMP Support

Gap analysis and CMC documentation preparation

GMP readiness assessment and strategic support

Technology transfer and compliance alignment

Labeling & Promotional Compliance

Regulatory review of labeling and advertising

Language adaptation and warning statements

Compliance with promotional material guidelines

Local Representation

NMPA Legal Agent services

Liaison with regulatory agencies and domestic communications

Regulatory Consultants for Marketing Authorizations

Medical Device & IVD Regulatory Services

As a medical device regulatory affairs consultant, we help manufacturers align with regulatory requirements, achieve product approvals, and stay compliant throughout the regulatory pathway.

Product Registration & Classification

Device classification and advice on the best pathway to market

Registration documentation preparation

Country-specific registrations

Testing & Clinical Requirements

NMPA type testing with on-site engineer supervision

Clinical trials and clinical evaluations setup and management when required

Clinical Evaluation Report (CER) preparation

Combination Products

Pathway development for drug-device combinations

Determining lead component and regulatory submissions

Coordinated handling with regulatory authorities

Quality Compliance & PMS

Pre-inspection readiness support

Post-Market Surveillance (PMS) programs

Adverse event monitoring and reporting

Local Legal Representation

Legal Agent and Local Responsible Person in various jurisdictions throughout Asia Pacific including China, Hong Kong and Taiwan

Regulatory excellence for cosmetics companies

Cosmetic Regulatory Services

As a cosmetic regulatory affairs consultant, we help companies ensure compliance with regulatory requirements in both China and Taiwan.

Product Filing & Registration

China NMPA general and special cosmetic filing

Taiwan TFDA notification and unified system submissions

New cosmetic ingredient registration and CIC filings

Responsible Person Representation

Appointed RP for China and Taiwan

Certificate management and regulatory submissions

Labeling, Packaging, & Claims Review

INCI verification and efficacy claims review

Taiwan and China label compliance

Fair packaging checks

Cosmetic Testing & GMP Compliance

Microbiological, chemical, toxicological, and efficacy testing

Cosmetic GMP audits and QMS alignment

SOP drafting and documentation preparation

Post-Market Surveillance & Cosmetovigilance

Adverse event monitoring and risk classification

Reporting system setup and trend analysis

Health Food & Supplement Regulatory Services

We act as a health food regulatory affairs consultant, supporting product development and helping companies achieve market access while meeting regulatory requirements.

Regulatory Classification & Filing

Product classification (health food, functional food, general food)

Health food registration and notification

Functional claim verification

Label & Ingredient Compliance

Ingredient and formula review against IECIC

Functional claims catalogue checks

Label validation and country-of-origin declaration

Safety & Functional Testing

Nutrient verification

Toxicological and efficacy testing

Approved lab studies for product development

Responsible Agent &  Post-Market Compliance

Legal agent services for health food

Ongoing compliance and surveillance support

Veterinary Medicines & Products

As a veterinary regulatory affairs consultant, we offer regulatory expertise for MARA and NMPA submissions to support marketing authorization of veterinary products.

Product Registration & Classification

Veterinary medicine registration with MARA

Feed additive filing and veterinary IVD approvals

Dossier and Safety Support

Registration dossier preparation and safety studies

Toxicology and residue coordination

Labeling & Authority Engagement

Label content review

Liaison with regulatory authorities

Industrial & Consumer Goods Regulatory Services

We deliver regulatory consulting for industrial and consumer goods, providing a flexible approach that supports global regulatory certifications and ongoing compliance.

Product Certification & Testing

CCC, CEL, CCCF, SELO, HAF 604, RoHS, SRRC, NAL

Factory audits and performance testing

Labeling & Customs Compliance

Review of technical labels, manuals, and packaging

HS code classification and tariff advisory services

Legal Representation & Ongoing Compliance

Domestic agent services

Lifecycle management and monitoring of regulatory changes

Why Work with Cisema?

One Partner, Full Lifecycle Support

From pre-market strategy to post-market compliance, we provide support to internal regulatory teams and ensure seamless lifecycle management.

Regional Reach, Global Presence

Based in Asia and Europe with a global team delivering global reach.

Cross-Industry Expertise

Pharma, biotech, medical devices, cosmetics, supplements, veterinary, industrial and consumer goods.

Proven Results

Over 20 years of regulatory submissions, regulatory expertise, and approvals to drive business success.

How We’ve Helped Clients with Our Expert Guidance

Read about how we work with clients to find solutions, bringing together deep industry knowledge with leading talent.

April 18, 2026

China Manufacture License Renewal for Level A2 Pressure Vessels

How Cisema Supported Inox Torres Group, S.L. in Successfully Renewing its China Manufacture License (SELO) for Level A2 Pressure Vessels

The China Manufacture License (CML), also known as the SELO license, is a mandatory requirement for manufacturers of pressure equipment intended for the Chinese market. Inox Torres Group, S.L.’s manufacturing site produces high-pressure vessels falling under the Level A2 scope. This license ensures compliance with China’s stringent quality and safety regulations for special equipment.

The Challenge: Managing SELO Complexity for High-Risk Equipment

Renewing a SELO license for Level A2 pressure vessels required careful coordination across regulatory, technical, and cultural dimensions.

Navigating Regulatory Complexity
Navigating the complex and evolving SELO regulatory framework, particularly for high-risk products under Level A2, required meticulous planning and real-time compliance updates.

Ensuring Audit Readiness
Inox Torres Group, S.L. needed to ensure all documentation and procedures were fully up to date and to select an appropriate demo product that met inspection requirements.

Managing Inspector Expectations
Success depended on understanding the unspoken cultural and procedural expectations of SELO inspectors, including hosting and on-site hospitality.

Our Solution: Full-Spectrum SELO Audit Support

Recognizing the high stakes of SELO license renewal, Inox Torres Group, S.L. engaged Cisema for comprehensive regulatory and strategic support.

Reviewed the Quality Management System
Cisema led the review and upgrade of the customer’s quality management system in line with the latest Chinese requirements, including a comprehensive gap analysis and revision of key documentation.

Audit Simulation & Preparation
A preparatory remote audit simulation was conducted, walking through every step of the audit to ensure full readiness ahead of the on-site inspection.

Delivered On-Site Bilingual & Regulatory Support
During the on-site audit, Cisema provided continuous bilingual support, interpreting inspector questions in real time and translating regulatory nuances for the customer.

Provided Culturally Appropriate Inspector Hosting
Cisema arranged culturally appropriate corporate hospitality, helping establish a respectful and positive tone for the inspection. The team remained onsite throughout all audit days, including the weekend, to ensure no detail was overlooked.

The Outcome: Successful Renewal Without Disruption

Through hands-on execution and close coordination, the SELO renewal process was completed smoothly and efficiently.

Secured CML Renewal with Full A2 Status
Inox Torres Group, S.L. successfully renewed its China Manufacture License for pressure vessels, maintaining its Level A2 classification.

Executed the Project Efficiently
Full regulatory preparation and audit execution were completed within six months.

Achieved Seamless Inspector Coordination
SELO inspectors were hosted and coordinated smoothly, with culturally aligned engagement throughout the audit.

Secured Regulatory Continuity
The renewal avoided operational disruptions and ensured compliance with updated SELO requirements.

Expertise and Efficiency: Acting as an Extension of the Client Team

Cisema’s experienced consultants acted as an extension of Inox Torres Group, S.L.’s regulatory and quality teams, providing both regulatory expertise and strategic foresight. Inspector concerns were anticipated and addressed proactively, transforming a potentially stressful process into a streamlined, well-orchestrated engagement with Chinese authorities.

Hands-on mentoring throughout the project helped the customer gain confidence and clarity in managing future SELO audits.

Why Choose Cisema

Strategic Regulatory Expertise: Deep understanding of Chinese bureaucracy, evolving SELO requirements, and inspector expectations.

Mentorship & Training: Step-by-step guidance that supported the customer’s quality team throughout the process.

Corporate Hospitality Excellence: Culturally aligned hosting that supports successful audit outcomes in China.

Audit Readiness & Precision: Gap analysis, audit simulation, and documentation refinement to pass SELO reviews efficiently.

End-To-End Support: Full management of the audit process, from document revision to on-site interpretation.

Further Information

Explore Cisema’s China Special Equipment (SELO) Certification services.

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