Biolink Pharma Consultancy

Regulatory Affairs Consultancy

Our mission is to help companies meet regulatory requirements, ensure compliance, manage product lifecycle and ensure successful product launches.

Training Courses

For young graduates, aspiring professionals and to upskill your regulatory team. Expand your skills and knowledge.

Advancing Regulatory Skills for Your Country

Helping countries build strong regulatory foundations through expert training and consultancy. BioLink Pharma equips local teams with the skills needed to meet standards and drive success in their markets.

About Us

As a UK-based consultancy with extensive expertise in regulatory affairs, BioLink Pharma is uniquely positioned to support businesses worldwide in building robust regulatory capabilities. Our mission is to empower companies in diverse markets by sharing industry-leading knowledge and upskilling local teams to confidently navigate complex regulatory landscapes. Through tailored training and hands-on consultancy, we help develop in-country expertise, enabling businesses to meet international standards and achieve smoother, faster product approvals. Partnering with BioLink Pharma means gaining access to trusted UK regulatory practices, designed to elevate local talent and drive success on a global scale. 

Middle East & North Africa (MENA)

Saudi Arabia, UAE, Egypt, Qatar, Kuwait

Sub-Saharan Africa

South Africa, Nigeria, Kenya, Ghana

Latin America

Brazil, Argentina, Mexico, Chile, Colombia

Southeast Asia

Indonesia, Malaysia, Philippines, Thailand, Vietnam

Asia-Pacific

China, India, Japan, South Korea, Singapore, Australia

Europe

EU Countries, Turkey, Switzerland, Eastern Europe

CIS (Commonwealth of Independent States)

Russia, Kazakhstan, Ukraine, Uzbekistan

Why Choose Us

With decades of experience, we provide personalised consultancy and training to fit your business needs. Our approach speeds up approvals, reduces time to market, and boosts competitiveness. From small tasks to full project management, we deliver precise, efficient, and top-quality results in regulatory submissions, document preparation, and strategic planning.

Trusted Regulatory Expertise

Decades of knowledge to guide your success.

Tailored Solutions

Solutions designed to meet your specific needs.

Professional Training

Building expertise for a competitive edge.

Our Services

At BioLink Pharma, we offer a full range of regulatory services tailored for pharmaceuticals, biotechnology and Healthcare Products.

Regulatory Consultancy

Both our in-house or remote services cover regulatory strategy development, dossier preparation & submission, Health Authority interactions and Lifecycle Management.

CMC Regulatory Affairs

Our in-house or remote consultants offer CMC expertise and knowledge to ensure compliance.

Clinical Trial Applications

Submit your CTAs, amendments and end of trial notifications in confidence with our knowledgeable consultants.

MAA Lifecycle Maintenance

Feel confident that your products will continue to be updated swiftly according to Health Authority guidance.

Gap Analysis

Our talented team can identify gaps in your dossiers, submissions and documentation and provide a bespoke remediation plan.  

User Testing

Let our experts deliver swift user testing for your patient information leaflets.  

Acquisitions

We manage smooth transfers of licences that need to be acquired or divested between companies.  

Pharma Consultancy

BioLink Pharma Consultancy offers effective solutions to meet your Regulatory Affairs requirements.
Our consultants provide the right amount of resourcing to ensure you have the correct level of support throughout the product lifecycle. Our team is well versed in global regulatory knowledge and across therapeutic areas. We pride ourselves on providing effective strategies resulting in regulatory approvals.