Aseptria was created to help bio/pharmaceutical companies in their efforts to outsource CMC activities.  The secrets to successful outsourcing relationships are:

· Effective project management, to identify ‘what’, ‘who’ and ‘when’

· Selection of the right contract service providers

· Active management of the relationship, from contract negotiation to day-to-day oversight

The outcome of well-managed pharmaceutical outsourcing includes:

ü Timely delivery of product and documentation

ü Proactive approach to resolve deviations

ü Anticipation to needs and requirements

ü Continuous improvement, efficiency and savings

Aseptria has the expertise and resources to ensure high quality service and customer satisfaction.

Our Services

· Master plan for CMC activities

· Definition of critical path steps

· Management of relationship with contractors

· Coordination of activities among CMC groups (internal and external)

CMC Project Management

· Pre-formulation studies

· Excipients screening

· Materials compatibility

· Container/closure selection

· Stability program

· Alternative dosage forms

Formulation and Process Development

· Supply chain planning

· Reporting of manufacturing and analytical results

· Correlation with clinical and regulatory processes

· Preparation of regulatory documents for filing

A CMC Project Manager sets and coordinates timelines, follows up with each responsible and provides feedback to management.  The Project Manager is the point of contact with contractors and the channel of communication.

Outsourcing Management

· Selection of contract manufacturing organizations (CMO)

· Selection of contract laboratories

· Quality / GMP compliance audits

· Technology transfer

· Process Optimization

Phone: (760) 525-3168

To contact us:

E-mail: info@aseptria.com

6431 Kiwi Place

Carlsbad, CA 92011-3608

Selecting the right contractor and establishing adequate conditions are key elements in a successful relationship.  Monitoring performance and anticipating changes ensure continuity in drug supply and compliance.

· Coordination of activities between contractors and vendors

· Monitoring performance and metrics

· Shipping coordination and qualification

· Quality reporting and release

Even when little is known about a new product, starting with a solid base will pave the road for growth and success.

· Single-use components implementation

· Packaging materials design

· Filter selection

· Lyophilization cycle development

· Blending studies

· Scale up

Choose and Customize the Service You Need!

Pharmaceutical Outsourcing Management- Consulting