Regulatory consulting services

Product Biologic drug substance CDMO services

From early development, including mammalian cell line development, cell culture development, and process development, through to pre-clinical production and commercial supply, Patheon by Thermo Fisher Scientific provides CDMO services for protein-based biologic therapeutics. Patheon offers biotech and ...

Product MS&T - Consulting Services

In the Life Science industry, robust processes and effective technology management are essential to ensure consistent product quality throughout the product lifecycle. S4BT provides comprehensive Manufacturing Science & Technology (MS&T) support, helping organizations manage, optimize, and validate...

Product Registration, Distribution and Networking Services

Registration, Distribution and Networking Services

Drug & Food Supplement Registration

Import and Custom Clearance

Tariff Planning and Optimization

Local Review and Authority Communication
Regional Sales & Mar...

Product GCP Services(Good Clinical Practices)

We offer various GCP services which can help the clients across globe, ranging from audits to monitoring services. We provide comprehensive GCP Quality Compliance services to the pharmaceutical industry. Our GCP consulting services are characterized by:

1) Knowledge: Various regulatory requi...

Product Regulatory Support

Zenovel has a highly experienced team of experts who have a complete understanding of the complete requirements of Pharma Regulatory affairs throughout the drug life cycle. Our experts have experience in directly corresponding with Pharma regulatory authorities for various segments.
...

Product PPWR Readiness Assessment for Pharma Packaging

Regulation (EU) 2025/40 (PPWR) has applied across the EU-27 since 12 August 2026. For pharma the exposure is uneven: primary packaging of medicinal products is exempt from the recyclability and recycled-content targets — but that exemption has to be documented, and secondary, transport and e-commerce packa...

PPWR Readiness Assessment for Pharma Packaging

Product Consultancy

Biological evaluation plans & reports (BEP & BER) Clinical evaluation plans & reports (CEP & CER) Submission support (US FDA, UK & EU MDR) Toxicological risk analysis Biological gap analysis PSUR (Periodic safety update report) Post market surveillance

Product Batch release

We take responsibility for releasing your drug batches in accordance with the requirements of the EU GMP guidelines and the German Medicinal Products Act (AMG).

Our services at a glance: • Batch release in accordance with EU GMP Annex 16 by our QPs • Batch certification for human and veterinary...

Product CDMO Services

Blow-Fill-Seal is the most economical way to get your liquids or semi-solids into the perfect shape. But investing in your own equipment doesn't always pay off. For these cases, there is our CDMO service. This means that you have a complete GMP infrastructure, bottelpack technology in various configuration...

Product Autoinjector development services

SHL Medical’s commitment to innovation has driven our leadership in the drug delivery industry. We offer vertically integrated development services to ensure the production of our self-injection systems are delivered with unparalleled speed, quality, and reliability.

Product Regulatory Support

Our Chemistry, Manufacturing and Controls (CMC) specialists help customers manage the product's compliance at every step, from clinical development to market authorization. With decades of experience, our experts provide support in navigating regulatory milestones, including site registration, product regi...

Product CARICOM Market Access and Regulatory Pathway

CARICOM is a set of markets with no single registration route. Manufacturers who could serve the region often do not, because the pathway is unclear and no one market justifies the effort on its own.

Barbados is building national regulatory capability, and regional review is available th...

CARICOM Market Access and Regulatory Pathway

Product Vicky

Vicky is an AI platform for legislation and compliance. It provides companies with a comprehensive overview of both EU and local legislation in one place, shows which obligations apply specifically to their business and what they entail, converts them into an auditable registry for team management and task...

Product CSV - Consulting Service

In the highly regulated Life Science industry, reliable and compliant computerized systems are essential for product quality, data integrity, and operational efficiency. S4BT provides Computer System Validation services throughout the lifecycle of digital and automated systems.

Our experts suppo...

Product GMP Services(Good Manufacturing Practices)

We offer various GMP services which can help the clients across globe, ranging from audits to various consulting services.

We provide following comprehensive GMP Quality Compliance services to the pharmaceutical industry.

• Audits

• API Audit Reports

• QMS/Complia...

GMP Services(Good Manufacturing Practices)

Product Pharmacovigilance / Drug Safety

We are an experienced and interdisciplinary team. Based on good pharmacovigilance practice (GVP) recommendations we provide comprehensive and individual support for all pharmacovigilance matters.

Pharmacovigilance services at a glance:
• Adoption of responsibility as EU-QPPV and graduated pla...

Product Regulatory Affairs Services

Regulatory Legal Framework

Regulatory intelligence

Dossier Preparation and compilation

Dossier Validation

Safety/Efficacy: bridging justification

Labelling & Artwork

Lifecycle Management: Preparation and sub...

Product SFDA Registration - Saudi Arabia

Drug registration in Saudi Arabia (Saudi Food and Drug Authority - SFDA).

Product Usability IEC 62366-1 as a service

Within 2 to 4 weeks, we can design and deliver batches ranging from 5 to 100 units, replicating the final commercial configuration of a medical device :
• High-fidelity device prototypes
• Precision labeling and marking
• Professionally formatted documentation (IFU, quick guid...

Product Regulatory Affairs

At YallaRx, we specialize in regulatory support for different product categories:

• Rx and OTC medicines • Dietary supplements • Cosmetics and perfumes • Medical devices
As the regulatory field varies in different countries of the world, we start with classifying yo...

Product Scope 3 Training Academy for Sourcing and Procurement Teams

Empower your sourcing and procurement teams to drive sustainability through expert-led Scope 3 training.
• Tailored, Expert-Led Training: Delivered virtually OR in person by SSC sustainability experts, with content customized to your company, industry, and supply chain. • Engaging and ...

Scope 3 Training Academy for Sourcing and Procurement Teams

Product Scope 3 Training Academy for Suppliers

SSC’s Scope 3 Training Academy offers comprehensive, instructor-led training to help suppliers measure, report, and reduce their greenhouse gas emissions while supporting your company’s sustainability goals.
• Live Expert-Led Training for Suppliers: A dedicated SSC sustainability expert deliver...

Product Life Cycle Assessment and Product Carbon Footprint

Life Cycle Assessment (LCA) serves as a basis for developing a baseline of environmental impacts, identifying environmental hotspots, and as a decision-making tool to enhance the new product development process.
A Product Carbon Footprint (PCF) utilizes LCA methodology to quantify...

Life Cycle Assessment and Product Carbon Footprint

Product GMP audits

Ideolon’s GMP audit services provide end-to-end solutions for supplier qualification, including audit planning, execution, CAPA follow-up, and closure. With experienced auditors and global regulatory expertise, we help ensure compliance with standards like USFDA, EMA, UKMHRA, ICH, and more.

Product Validation

Our team of experts will prepare necessary protocols incorporating all critical parameters

Process Validation:

PharmEng professionals possess experience in validating pharmaceutical and biopharmaceutical manufacturing processes. Our team of experts will prepare necessary protocols i...

Product License Holding Service

License holding service for Drug in SEA

Product Import Handling and Distribution

Import Handling and Distribution service in SEA countries

Product Drug Registration

Regulatory Service Provider

Product Automation Engineering Solutions

We provide solutions and technologies that reduce human intervention and increase efficiency.

Automation is offered in DCS projects independent of the automation vendor. We offer professional services in implementing Automation process control and maintenance in accordance with industry standards ...

Product Commissioning & Qualification

Our qualified consultants strive to exceed your project goals and objectives

Our flexibility and project experiences range from the qualification of an individual piece of equipment to an entire facility.
Our PharmEng professionals have extensive experience in the development, imple...

Product Trademark, copyrights, Regulatory affairs, PV, Translation

Atop pharma solutions is a global leader in regulatory, pharmacovigilance, legal and translation services. We support pharmaceutical companies to meet their regulatory requirements in all the key markets like Europe, North America, Asia, Africa and Latin America. We believe in helping pharmaceutical c...

Trademark, copyrights, Regulatory affairs, PV, Translation

Product Medical Writing

Emtex offers worldwide professional medical writing and related services to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions.