Amerigen Life Sciences has a team of technical experts who are experienced in various Pharmaceutical aspects and that team gives consulting services for many different fields in the pharmaceutical industry.
Research & Development:
We adopt a Quality by Design (QbD) approach, applying and challenging possible technologies and techniques in order to deliver the optimal product profile and performance in a timely and efficient manner.
We have capability for early stage API characterization, formulation, and analytical development through to process development, scale-up, and technology transfer for commercial manufacturing. We also support 505(b)(2) regulatory pathways. Our facilities and teams are designed to provide you the greatest flexibility while maintaining quality services.
We offer proven expertise in providing regulatory-compliant parenteral product development for regulated and semi-regulated markets.
Formulation development is an elementary part of Pharmaceutical Industry. We completely understand the importance of our customers for development of their new product requirements.
Amerigen’s formulation development services are entirely focused on fulfilling client’s requirements, with collaboration with its group company Amerise Pharmaceutical Pvt. Ltd. Amerigen provide services for whether be it generic or branded along with all regulatory compliance required in to achieve market demand.
Our team of expert formulation professionals along with their profound knowledge helps our customer to arrive at the best dosage form for their raw material and Application. We completely bound ourselves to the timelines of our customers to achieve great results and fulfil their market demands. We at Amerigen constantly endeavour to establish all quality aspects and regulatory requirements to ensure smooth and efficient manufacturing of our customer’s product.
While developing formulations we always keep in mind client’s expenditures so as to develop a profitable product in order to remain competitive in front of this constantly evolving market.
Amerigen is continuously leveraging its vast experience in Contract Manufacturing, Quality and Regulatory Affairs in order to extend maximum benefits to our esteemed customers across the world. We provide customized manufacturing of products on the client choice of brand name and packaging in terms of attractive designs and quality material along with sufficing regulatory requirements.
Partnering with Amerigen helps its customers to achieve efficiency and exceptional quality along with flexibility to adopt to their market and values. Our in-depth Contract Manufacturing experience enables us to understand the challenges faced by our customers and to settle those challenges quickly in order to get their products in market faster.
With a portfolio of more than 175 products, it makes us one of the ideal Contact Manufacturing Company for our customers in Pharmaceutical Industry. This business model also ensures that the customers are met with all kinds of necessities at the best.
With a global manufacturing experience and an in-house regulatory affairs team, we are very much disposed for partnering and collaborating with our customers.
AmeriGen offers specialized services in clinical trial management using a global network of assets, experience, and expertise in streamlining the clinical trial process.
AmeriGen provides a wide range of high-quality writing services for the Biotech, Pharmaceutical, and Medical devices companies across the Globe. Our team of qualified and experienced Medical Writers is well expert to write a wide range of Regulatory, Clinical, Scientific, and Marketing communication documents.
Medical Writers can help you to prepare clear, concise, and high-quality reports and documents for Regulatory Submissions, publications in peer-reviewed medical journals, and effective marketing communications.
OUR MEDICAL WRITING FOCUS AREAS
- Review articles
- Slide decks
- Advisory board meetings
- Informed Consent
- Clinical Study report
- Clinical Overview
- Clinical Summaries
- Clinical Evaluation report
- Manuscripts, posters, abstract
- Systematic Literature Review
- Literature Searches, disease landscape, pharmacoepidemiology
- PRO Selection,
- Evidence Gap analysis
We always believe that Regulatory affairs are “Backbone of Pharma Industry”. Our in-house regulatory team has achieved great outcomes by constantly working and acting as an interface between our customers and their respective regulatory agencies and regulatory affairs departments spread across the Globe to achieve smooth transmission of information and compliances.
Amerigen Life Sciences provides complete support from product registrations to final regulatory agencies and tries to accomplish all activities to obtain product approvals/marketing authorization.
Our team has in depth and extensive knowledge of regulatory requirements in almost all markets across the globe. This helps us to achieve great results against ever-changing challenging market and regulatory requirements. Also, our team has level best experience of submissions associated with almost all therapeutic categories which ensures our customers that they are at right place and can access our expertise at each stage of regulatory requirements.
Our team is experienced in preparing the dossier as per requirement of various regulatory authorities of respective countries in CTD, ACTD or any other customized format for product registration.
Amerigen team can provide one stop solution for product development starting from API sourcing to technical requirement of equipment/machineries to formulation development from lab scale to commercial development to packaging along with on-site service as and when required.
Amerigen’s expert team can provide the inputs and guidance on new product launch, formulation, dosing, packaging aspects, patented molecules suggestions (subject to patent law of country) as well as technical assistance in terms of marketing strategies and promotional literature.