Our Services

Alava provides strategic, technical and regulatory support for biopharmaceutical product development. Our goal is to help develop high quality and cost-efficient strategies, and then supply the technical and management support to succeed on schedule. If a virtual approach is best for a company, Alava has the depth and integration to coordinate and streamline the CMC and regulatory activities, minimize disruptions and optimize the path to commercialization. If you need an individual to fill a management or experience gap, or troubleshoot a technical problem- Alava can help. Our experience with key vendors and the contracting process will save time, and reduce mistakes and conflicts.
Alava participates in the business of biopharm as well as CMC activities. Our team has experience with venture capital financing, board membership, and CEO/COO responsibilities. For investors, M&A assessment and in-licensing, Alava can help assess technical and CMC-regulatory risk, development plans, and team capabilities. For product developers, we can help prepare plans, budgets and diligence materials, and address topics that could endanger a deal.

Our areas of expertise

  • Development and budget planning
  • Investor due diligence
  • Partnering assessment and diligence

Technical Development

Alava’s scientists and engineers have carried numerous products through early development, transition to pivotal trials and commercial operations, and launch. Biotechnology products are complex and regulatory expectations evolve rapidly, so a robust technical development program will be critical for success. Outsourced technical development is less straightforward than GMP manufacturing or testing, so vendor selection and management is critical. For a lean program, Alava will help find an approach to reach the next milestone with acceptable cost and risk. For clinical stage development, we can develop programs for yield and consistency improvement, and apply DOE and QBD approaches to development activities. For biosimilars and transition to commercial-ready production, we can develop comparability and validation strategies, support scaleup and tech transfer, and help prepare for pre-approval inspections.

Process and Product Development Expertise:

  • Cell line development and GMP banking
  • Supply and characterization of tox material
  • Upstream process development
  • Downstream process development and viral clearance studies
  • Process ranging studies
  • Formulation and drug product development
  • Stability assessment, shipping and storage
  • Small molecule synthesis and purification
  • Drug delivery
  • Tech transfer
  • Clinical administration support

Analytical Expertise:

  • Cell based and potency bioassays
  • PCR and sequencing
  • Chromatography and LC-MS
  • Gels
  • Impurity assessment including HCP, HC-DNA and product variants
  • Small molecule chemistry assays
  • Stability indicating assays
  • Quality attribute assessment
  • Consistency and comparability studies

GMP Operations and Quality Control

GMP material supply represents one of the major costs and risks for a biopharmaceutical project. Technical capabilities, on-time performance and GMP compliance are all needed for success. Alava has the experience to assess, install and manage all aspects of GMP drug substance (API) and drug product manufacturing, testing and distribution.

  • Manufacturing planning and management (including person-in-plant)
  • Batch record preparation
  • Quality Control systems and sample management
  • Specifications and reference standards
  • Stability studies: real-time, accelerated/stressed, shipping and product compatibility
  • Aseptic operations, QC microbiology and environmental monitoring
  • Adventitious agent testing for banks and batches
  • Supply Chain (inventory management, shipping, storage, distribution)
  • Method and Process Validation

Project Management

CMC activities require close management and coordination, especially when success depends on outsourced activities. An optimal and timely program will reflect supply considerations, but also the connections between concurrent process development, method development, stability assessment, reference standard qualification, specification development and change control. At the start of a project, the PM can play a key role in establishing the project timing, resource and budget requirements, key deliverables and accountability. Risks and contingency plans are documented to support corporate planning. As activities proceed, the PM will organize meetings, work with team members to track progress and budget, obtain decision support when needed, and follow up with responsible parties. Deliverables and vendor performance are assessed before closing out activities and authorizing payments.

If a client has project management support for CMC activities, Alava team members can take care of the project tasks. If support is needed, Alava will supply an experienced CMC-focused project manager and help integrate CMC with clinical, regulatory and operational aspects of the project.

A majority of Alava clients request Quality support as part of the project scope, and the team has expanded to provide excellent depth and value at levels from manager through VP. We monitor current US and international regulations, guidance documents and enforcement trends. Alava specializes in addressing sponsor responsibilities for outsourced activities, and finding an appropriate approach for novel or challenging technologies. Alava can carry all QA-related responsibilities requested by a sponsor including product disposition.

  • QA document system startup and maintenance
  • Quality Agreements for CMO’s and testing labs
  • Batch Record and Testing Record review and approval
  • QA audits and Pre-Approval Inspection preparation
  • Facility and utility validation and compliance
  • Investigations and compliance remediation
  • Support for stage-appropriate method and process validation
  • Documented training
  • Review key technical and nonclinical reports

Regulatory strategy, submissions and communications are critical in order to achieve timely progress and maximize the value of your project. Alava offers strong experience, deep and current knowledge of regulations and expectations, and value in Regulatory Affairs support. Our features and services include:

  • Multiple VP-level consultants with FDA and international experience
  • Broad experience with product categories including gene therapy, devices, biologics and small molecules
  • Experience from preclinical stage through post-marketing
  • Organizing, writing and reviewing regulatory submissions
  • Planning and conducting regulatory meetings including pre-IND and pre-license application meetings
  • Publishing services including eCTD format
  • Requests for fast track, breakthrough therapy, priority review and orphan drug status
  • U.S. Agent representation

Alava is focused on the selection and management of outsourced CMC operations as a core service. We will work with you to capture the substantial benefits of outsourcing, while reducing the associated costs and risks.

The overall CMC outsourcing process includes the following steps:

  • Agree on the company’s development goals and strategy, taking into account timing and budget factors, and the company’s long-term vision.
  • Develop a preliminary CMC project plan and budget and gain internal buy-in
  • Identify the vendors with the best fit of capabilities
  • Prepare RFPs to obtain clear agreement on project scope and deliverables, and identify gaps
  • Review and followup of RFP responses, and reference checks
  • Negotiate service agreements and quality agreements
  • Manage the contracted activities, including regular project meetings and documentation of issues and decisions

Alava’s experience with the top CMC vendors and the outsourcing process will save time and get you to the best outcome with the lowest risk. Alava has the technical power and depth to help you outsource and manage challenging process and analytical development activities with confidence, as well as GMP activities.