AMBIPHARM WELCOMES YOU

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LIFE SCIENCES CONSULTING

I have the knowledge and experience to meet and exceed your expectations, and offer a variety of services customized to fit your specific needs. Learn more about the improvements I can help you achieve, and contact me today.

My clients are my number one priority, and my services prove just how committed I am to their success. Book an introductory meeting today to learn more about how I can make your business thrive.

GMP AUDITS

We provide Good Manufacturing Practice (GMP) auditing for regulated industries that manufacture, test, store, and distribute therapeutic products. With a diverse range of technical and regulatory compliance experience, we can address clients and suppliers in Pharmaceutical and Biotech.

We also perform due diligence compliance inspections, audits and assistance.

Ambipharm has experience with FDA, EU and other major regulatory health authorities.

To find out more get in touch.

COMPLIANCE

Ambipharm has a vast experience in Quality, Compliance and Regulatory Affairs.

We help you in Quality Systems, Documentation review, Specification writing and review of critical documents for regulatory filling.

We can assist your organization in writing regulatory documentation while ensuring regulatory compliance that maximizes the chances for health agency approval.

Tell us where you want to file and we provide you the strategy.

Ambipharm has vast experience planning and writing skills of your regulatory submission.

We can assist you in FDA, EU and RoW fillings.

Expertise dosage forms: Sterile (aseptic filling), Oral drugs

We focus on CMC sections, Labelling and Market assess.

Get in touch!

TECHNOLOGY TRANSFER

Technology transfers are complex projects that require a coordinated effort from almost every part of your organization.

A pharmaceutical or biotechnology, firm looking to execute a technology transfer can certainly expect the need to balance the integration of quality, regulatory, schedule, and cost, regardless of the complexity of the project.

We have a program/project management approach for these assignments.

RESPONSIBLE PERSON/ GDP AUDITS

The Responsible Person is responsible for safeguarding product users against potential hazards arising from poor distribution practices.

The wholesaler distributor must designate a person as a responsible person. This should meet the qualifications and all conditions provided by the legislation in the Member State concerned.

Ambipharm has the know how, and can assist you in bringing your products faster and safer to the market.