Services

Research processes that are not followed, lack clarity, or are cumbersome can complicate a research study or, worse, set the stage for noncompliance. We help evaluate your project’s/program’s weaknesses and address your needs, helping you conduct well-controlled, compliant clinical research trials. Our consultants can help you earn regulatory approval (from the FDA and/or international regulators). We achieve this by guiding teams through the entire clinical trial lifecycle. We also offer assistance with particular elements of the process, providing consulting, independent monitoring, auditing, data management, strategic services, and more.
Our Services includes the following:

Our consultants help accelerate clinical development with a comprehensible strategy, operating model design, and process optimization – all with efficient governance. Our expertise across consulting, strategy, technology, and operations assists our clients as they work to streamline their clinical development programs.

We identify and support label claims and strategies for efficient product application, regulatory strategy planning and offer assistance with CTAs, INDs, NDAs, and MAAs. We also help with pharmaceutical and biopharmaceuticals GMP and GLP compliance, compliance strategies, and due diligence assessment. Our clinical development services refine clinical strategies and operations and provide the following:

• Clinical development strategy (IPDPs).
• Clinical development plans (CDPs).
• Developing target product profiles (TPPs).
• Understanding current standards of care (treatment guidelines).
• Mapping the competitive landscape.
• Match indication to asset – selecting indications to best suit the strengths of an investigational agent.
• Medical/clinical support with regulatory interactions.
• Operational support.
• Preparing dossiers and submissions.
• Developing clinical study protocols (CSPs) and Investigators Brochures (IBs).
• Medical Monitoring.
• Clinical Governance.

Build drug safety departments and provide guidance on all aspects of the pharmacovigilance process to ensure compliance with current regulations and a framework that aligns with your product lifecycle.

• Safety Risk Management Strategy (SRMS)
• Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategy (REMS)
• Individual Case Safety Reports (ICSRs) and Expedited reporting
• Signal Detection and Evaluation including literature screening
• Aggregate Reports – DSURs, ASRs, PSUR/PBRER, PADERs, RSIs
• Coding Thesauri – MedDRA; WHO Drug Coding
• Safety Review Committees – SMCs/DMCs
• Pharmacovigilance Training
• Safety Data Exchange Agreements (SDEA)
• Ensure integration of other functional areas into pharmacovigilance statutory requirements

• Devise effective regulatory strategies to overcome critical hurdles
• Dossier preparation and submission
• De-risk regulatory interactions – submissions and responses – and provide ongoing support in interactions with the FDA, EMA, MHRA, Health Canada, TGA, ANVISA, other national regulators

Offers expertise and innovative solutions for the following areas:

• Medical Communications
• Medical Education
• Medical Information & Safety
• Medical Research
• Medical Science Liaisons
• Patient Support Programs

Our strategic advice is based on therapeutic class individuality, specific aspects of the asset (formulation, route of administration), concerned FDA expectations, target population, and disease indication. We help our clients meet the challenge of developing new products against a landscape of complex regulation, thinning opportunities, and changing physician, payer, and patient expectations.

We help you make regulatory interactions less risky (submissions and responses) and provide ongoing, hands-on regulatory support when interacting with the FDA, EMA, MHRA, Health Canada, TGA, ANVISA, and other national/international regulators. Our strategic development services offers analysis, assessment, and strategic advice on life science intellectual properties (IPs) to maximize IP portfolios and include the following:

• Opportunity Mapping and Business Strategy
• New Product Planning and Launch Planning
• Work with your business development team to find, evaluate and assess new assets
• Asset Scouting and Due Diligence
• Pharma and Biotech Valuations
• Licensing and Deal-Making