Services

service

SMALL MOLECULE API DEVELOPMENT

At AffordGen, we pride ourselves on solving your API development challenges to help speed your molecule through early-phase trials and achieve industry-leading performance. Partner with us for quality and excellence in small molecule development, whether you need small quantities for initial development work or many kilograms for a late-phase trial.

SMALL MOLECULE PRODUCT DEVELOPMENT

AffordGen solves API development challenges to speed up molecule trials and guarantee quality. Partner with us for excellence in small molecule development, from start to finish.

Address formulation challenges such as bioavailability, stability, and solubility
Navigate a complex regulatory environment
Build success in early development to enable commercial success
Shorten timelines to get to market more quickly
Ensure a robust supply chain within a global network

- Small molecule product development.webp

TECHNOLOGY TRANSFER

AffordGen provides expertise and agility for technology transfer throughout the drug lifecycle. Our trusted approach ensures a quicker, simpler, and seamless tech transfer process with full support at every stage. Our experienced team and ongoing training enable efficient and successful transfers. We also offer development and testing capabilities for commercial scale-up, making us a one-stop shop for changing manufacturing supply chains.

THIRD-PARTY MANUFACTURING

AffordGen provides clinical trial material and commercial supply services to organizations of all sizes. We have a range of specialist capabilities and strategic collaborations with various types of manufacturing sites suitable for regulatory and semi-regulatory categories such as prescription, OTC, nutraceuticals, and cosmetic products. Our expert team is experienced in managing the complexity of processes and projects, helping to reduce risk and maximize the chance of your project succeeding.

CLINICAL RESEARCH SERVICES

AffordGen offers a one-stop solution for conducting Bioequivalence Studies and Clinical Trials in India. Indian CROs are known for their regulatory-compliant system, affordable study cost, and timely completion. AffordGen helps select experienced CROs to utilize their expertise for a cost-effective study outcome.

Independent study monitoring (As Per GCP E6R2) for BA/BE and Clinical Trials
Audits
Consulting – Protocol drafting, Study design
Collaborating with CROs
Arrange cost-effective quotation

STRATEGIC SOURCING

AffordGen sources high-quality and cost-effective active pharmaceutical ingredients (API) to meet clients' needs. Our sourcing services include a global strategy based on customers' business requirements. Our team manages a global supply network of manufacturers, ensuring compliance status. During formulation development, we work closely with our scientists and suppliers to streamline the overall development timeline. During the commercial phase, we coordinate deliveries directly with suppliers, improving the visibility of incoming raw material supply, which helps avoid production downtime and reduces costs. Utilizing AffordGen global scale and capabilities will enable clients to shorten their product development lifecycle by around 20-30% and take comfort in knowing their supply chain is secure from molecule to medicine.

The service items contain:

API
Excipients
Packaging material
Ready to compressed granules
Ready to fill pellets

INTELLECTUAL PROPERTY SERVICES

AffordGen uses Patent Databases and Analytics tools for other customized projects for Business Research, especially for Competitive Landscapes, Technology Research which includes state-of-the-art searches and Technology Landscape/White Space Analysis, and Legal Research which includes Patentability Searches, Evidence of Use, Validity/Invalidity Searches, and FTO or Third- Party Patent Clearance Searches.

AffordGen offers the following services:

Product and market-specific patent landscape preparation
Draft the Patent application for applying a maximum number of jurisdictions
Accelerated Examination Search & Filings in India
Opposition Search & Filings
Patent Drafting
Technical Analysis of Office Actions & Oppositions
Drafting Response of Office Actions & Oppositions
Patent Illustrations

Facility

Center of Excellence

AffordGen has State-of-the-art small molecule finished-product development and technology transfer at own and client’s manufacturing facility

The Center of Excellence (CoE) is GMP-approved with well-equipped for the development of generic products, as well as for reformulation and life cycle extension of existing molecules. The use of process analytical technologies and Quality-by-Design (QbD) tools demonstrates a commitment to producing high-quality pharmaceutical products efficiently. The following dosage forms are being developed at CoE.

All dosage forms mentioned below shall be developed for Regulated Markets - USA, EU, ANZ

Manufacturing

AffordGen commitment to providing world-class quality medicines at affordable prices to work towards a healthier and happier world. Affordgen has established a culture of manufacturing excellence from the beginning and is committed to maintaining it through continuous improvement and investment. AffordGen is committed for -

Culture of Manufacturing Excellence
World-Class Facilities
Continuous Improvement
Skill Development
Quality and Compliance
Agile Manufacturing

AffordGen reflects a strong focus on manufacturing excellence, quality, and adaptability, which are all important factors in staying competitive in the manufacturing industry.