Offered Services

Process Development

~ Energy positive / cost effective process development

~ Robust process development for error free execution

~ Smooth transfer of developed technology to the commercial site

~ GMP complaint documentation

Technology Transfer

~ Dossier compilation for various markets (Non regulated, semi regulated)

~ DCGI Application for new product approval

~ Query compliance for product registration

Regulatory Support

~ Generic development for oral solid

~ On site trials and execution

~ Improvement in existing products

~ NDDS

Formulation Development

Expert Formulation Support

We have the team of experienced professionals in different areas such as F&D, analytical development, technology transfer, regulatory affairs and production.

We can make your products, processes and production practices more cost effective.

We can provide technical support to your existing set up to enhance the productivity in compliance with the global regulations.

We can fasten up your product registration process by providing competent quality documents and can be technical support in replying the regulatory queries.

Hetero Analytical offers Formulation & Development - Analytical Testing Laboratory in Ahmedabad

Our expert team includes professionals from formulation & development, analytical research, technology transfer, regulatory affairs, and production. We help make your products and processes more cost-effective and efficient. By supporting your current setup, we aim to improve productivity while staying fully compliant with international standards. We also assist in speeding up your product registration by preparing accurate documents and helping you respond to regulatory queries with confidence.

Expert Technical Support

Formulation & Development

Formulation N Development Hetero Analytical

Taking a pharmaceutical product from concept to commercial manufacturing is a complex, multi-stage process. Formulation development requires not just scientific expertise but rigorous analytical testing at every step — to confirm that the formulation is stable, effective, and manufacturable at scale. Hetero Analytical Solutions LLP supports pharmaceutical companies, research institutions, and startups with analytical services throughout the formulation development lifecycle.

Analytical Support at Every Stage

Pre-formulation studies — physicochemical characterisation of API (solubility, pKa, polymorphism, hygroscopicity)
Excipient compatibility studies — DSC and HPLC-based compatibility screening
Method development and validation — HPLC, UV, GC methods for assay and related substances
Prototype batch analysis — testing of lab-scale batches against target specifications
Stability studies — accelerated (40°C/75% RH) and long-term (25°C/60% RH) as per ICH Q1A
Dissolution profile studies — comparative dissolution for ANDA/bioequivalence submissions
Particle size and morphology analysis
Process analytical testing during scale-up
Certificate of Analysis generation for development batches

Supporting Regulatory Submissions

Data generated in our laboratory for formulation development projects is documented in compliance with GLP principles, making it suitable for inclusion in regulatory dossiers — ANDA filings with US FDA, CTD dossiers for EU submissions, and CDSCO new drug applications. We work with your formulation scientists to ensure the analytical strategy aligns with the target regulatory pathway from day one.

Speed Without Compromise

Early-phase formulation work often operates under tight timelines. Our team prioritises quick turnaround for screening and compatibility studies, giving your development scientists fast feedback without sacrificing the rigour required for regulatory acceptance. We communicate proactively when results suggest formulation issues — helping you course-correct early rather than late.

From Lab to Launch

We have supported companies from initial API characterisation through to stability data packages ready for product registration. Our long-term engagement model means we become an extension of your development team — familiar with your molecules, your regulatory targets, and your timeline pressures.

For formulation development analytical support in Ahmedabad and Gujarat,
Contact Hetero Analytical Solutions LLP at +91 98166 18822.