Solutions

AZURA Life Sciences, LLC helps pharmaceutical companies develop and execute innovative strategies to meet regulatory, compliance & quality assurance, safety & pharmacovigilance, and project management challenges and emerging trends that drive business needs. With more than 20 years of experience collaborating with the FDA, EMA, MHRA, TGA, PMDA, NMPA, Health Canada, and other regulatory agencies globally, we offer leading pharmaceutical strategy and guidance.

Our compliance consultants and regulatory experts understand industry complexities and provide strategic insight on the unique intricacies within the various regional regulatory processes. 

Regulatory Affairs

Regulatory Affairs is the backbone of our business and, as such, our focus is on developing innovative development strategies specific to the different types of drug products, whether it be pharmaceutical, biologic, cell/gene therapy, medical device, or any combination thereof.

• Discovery to post-approval lifecycle management

• Preparation for regulatory agency meetings and briefing packages

• Special Protocol Assessment/Scientific Advice

• Preparation/review of marketing applications and new product launch material

• Orphan Drug, Fast Track, and Breakthrough Therapy designations

• Global regulatory submission planning and strategic support

• IND/CTA preparation

• Medical writing support of regulatory documents

• Strategic consulting and regulatory intelligence

• Preclinical and CMC consulting 

Quality & Compliance

Increasingly, life sciences companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it's preparing for an audit, developing a response to a regulatory agency finding, or remediation of an adverse event, we can help.

• Current GXP support

• Corrective and Preventative Actions, investigations, and deviations

• Data integrity and Quality metrics

• Implementation of Quality Management Systems/quality system gap assessment

• Comprehensive supplier, CRO, and cGXP audits

• Inspection preparation, training, and readiness

• SOP development, training, and implementation

• Document management and change control

• 483, Warning Letter, and Consent Decree response preparation

• Remediation plan development and implementation

Safety & Pharmacovigilance

In the constantly changing regulatory climate, we will work with your organization to ensure compliance with current FDA and international regulations and guide you to build the framework that aligns with your product lifecycle. Together, we will support your company’s expedited and periodic submission compliance.

• FDA and International Regulatory Audit Preparedness

• Timely SAE Case Processing

• Drug Safety Narrative Writing

• Signal Detection and Evaluation

• Consistent MedDRA/WHO Drug Medical Coding

• Drug Safety Team Training

• Drug Safety Team Development

• Development/Periodic Safety Update Reports

Project Management

We’re passionate about helping emerging life science companies grow at every turn, from drug discovery and early clinical stages to product launches and beyond. Whether its corporate needs analysis, corporate growth/transformation strategy, or due diligence/acquisition, we can ensure a successful mix of novel advice and talented professionals so your timelines and budgets are met while avoiding detrimental mistakes.

• Mergers and acquisitions/regulatory due diligence support

• Portfolio Management

• Cross-functional budgeting 

• Project planning, execution, and tracking