Alava was formed to provide technical, strategic and management support for the development, manufacturing and testing of biopharmaceuticals and small molecules. Our approach is customized to each client’s needs, from traditional consulting, to interim or supplemental management, to taking full responsibility for designated CMC activities including preparation and maintenance of associated regulatory documents.

Alava’s versatile team members have each worked for over 15 years in product development companies as well as consulting. Every project is unique, and Alava has the experience to understand and achieve the best quality, speed and value for your product. Each Alava consultant has managed vendor selection and management of outsourced development, testing and manufacturing.  We can plan and execute projects, work with investors and boards, and produce the high quality CMC-regulatory submissions that are critical for success.

Why Alava

Strategic vision

Our strong executive experience in biopharm and understanding of the drug development process helps us find the best CMC approach to build project value and meet the goals of each business.

Top notch science

Every biopharm project has its technical challenges. Our team has the technical training and industry experience to solve tough problems, mitigate technical risk and implement effective solutions. We understand that superior science can provide a competitive advantage, and may be critical to keep your project on track.

Experience in startups and lean environments

Often the best technical solution is not workable because of timing, budget or logistics constraints. Alava will work creatively to find the best path for a project, reacting to threats and opportunities and reflecting the company’s overall strategy and options.

Project management support

A successful biopharm project requires more than individuals executing a list of tasks. Alava offers dedicated CMC project management support as needed, so that activities are coordinated, documented, timely, and mesh with corporate and program management goals. This support includes ongoing budget planning and management.

Commitment and depth

Individual consultants provide important support to the industry, but working with Alava has some key benefits. Alava has multiple experts in each field to provide depth and project continuity, reducing the risk of interruption or losing a key resource. We are committed to your success, and will work flexibly to supplement your in-house team and consultants.

Positive relationships

Every project depends on teamwork, effective communications, and relationships- so our team members are good listeners as well as experts. Our goal is to build durable and positive relationships with our CMO/CTL partners and networking partners as well as every client.