Pharma & Biotech Expertize
Around 30 years experience in manufacturing environment. ​
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 us today.
My clients are my number one priority, and my services prove just how committed I am to their success.
The improvement of patient health is your moto,
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.
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We also perform due diligence compliance inspections, audits and assistance​.
Ambipharm has experience with FDA, EU and other major regulatory health authorities.
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To find out more get in touch.
COMPLIANCE
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Ambipharm has a vast experience in Quality, Compliance and Regulatory Affairs.
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We help you in Quality Systems, Documentation review, Specification writing and review of critical documents for regulatory filling.
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We can assist your organization in writing regulatory documentation while ensuring regulatory compliance that maximizes the chances for health agency approval.
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Tell us where you want to file and we provide you the strategy.
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Ambipharm has vast experience planning and writing skills of your regulatory submission.
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We can assist you in FDA, EU and RoW fillings.
Expertise dosage forms: Sterile (aseptic filling), Oral drugs
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We focus on CMC sections, Labelling and Market assess.
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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.
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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.
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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.
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Ambipharm has the know how, and can assist you in bringing your products faster and safer to the market.
Contact us for more details
Program Management / Customer Relationship Management
We are proud to lead multinational, virtual, cross functional teams, in matrix organisations. Managing programs and giving back to our customer customers the fruits of our exceptional work as a team. From E2E, pre-clinical, clinical and commercial products. Development and manufacturing of Active Drug Substances up to Drug Products. Using different technologies and dosage forms. Leasing with customer benefitting our partner and vice versa, leading into win-win situations. Contract Manufacturing, Complex projects are our forte!
Empowering local know-how towards global recognition in biotech.
From Portugal to the World.
Coming soon!
VALUED CLIENTS
Partnerships and Projects
Cell & Gene Therapies
Technology Transfer, Program Management
Geographic Expansion, Oncology drug products and APIs, Generics
Manufacturing, Science & Technology
Program Management
Mammalian (mAbs), mRNA Technology Transfer, Program Management
Business Development
Microbial, Bioconjugates, Technology Transfer, Pre-clinical, clinical & Commercial Program Management
CONTACT US
