We’ll help you conquer the complexities.
The biologic product development framework brings regulatory challenges and complexities unseen in the traditional pharmaceutical development process. DR. SSK LABS PVT. LTD. is a full-service firm offering the full-scope of regulatory and product development consulting for your biologic product.
Our mission is to provide counsel and critical insights into FDA thinking throughout the biosimilar product development lifecycle. Our team of world-class consultants brings decades of experience at every stage:
FDA Interactions & In-Person Meetings
Pharmacology/Toxicology
Quality Management
Product Manufacturing
Medical Device Biocompatibility
Clinical Trial Design and Evaluation
Immunogenicity Assessment
GMP, GLP and GCP Regulatory Compliance
Regulatory Applications & Submissions
Let’s advance the future of modern medicine, together.
DR. SSK LABS PVT. LTD. is proud to offer more than consulting services and regulatory support to our clients by providing a full scope of biotech product development consulting services. In doing so, we look at every project through the lens of the patient. For us, success doesn’t only mean successfully guiding you through the regulatory process but making a positive impact on the end-user.
We bring together innovative approaches, world-class science, regulatory know-how and a dedicated team to deliver solutions that improve patient access and quality of life for patients
Every Step of the Way
We provide services to deliver impactful solutions at every stage of your product’s lifecycle, from nonclinical testing and verification through manufacturing, design and evaluation of clinical trials to commercialization.
Not only do we want to guide you through each step of the process, we want you to achieve commercial success.
Step 1
Learn, understand and assess the client’s needs.
Step 2
Research, collaborate and plan the pathway to success.
Step 3
Align strategically and draft an action plan.
Step 4
Execute and finalize the strategic plan and next steps.
Ready to change lives?
How we help
Consulting Services
Regulatory Strategy & Due Diligence
FDA Meeting Preparation & Engagement
FDA Submissions
Clinical Development
CMC Development
Audits
Support Services
Medical Writing
Project Management
Electronic Publishing & Submissions
Staff Augmentation
Due Diligence
Contact an Expert
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