Welcome to Episteme
Creating value.. Delivering Excellence..
Vision, Mission & Values
To establish Episteme as a reliable and result-oriented consultancy entity deploying our ability to deliver excellence at all times.
Read MoreFounder
Ms. Nayna Daptardar
Nayna has the utmost dedication and passion for excellence, having 36 + years of pharma industry experience. She has ability to lead from front and a proven track record of success in field of regulatory affairs. She began her career in a quality control lab and has learned regulatory requirements ground-up. She is very well-versed in latest regulatory requirements and has hand-on experience for highly complex dosage forms. She is a transformational leader and an excellent mentor.
Vision, Mission & Values
Vision
- To establish Episteme as a reliable and result-oriented consultancy entity deploying our ability to deliver excellence at all times.
- To gain recognition as a leading pharma regulatory consultant with a proven ability to bring value to our clients.
- To earn a reputation as a regulatory specialist for highly complex dosage forms.
Mission
Our mission encompasses the following key deliverables;
- Rendering excellent services and utilizing our expertise and insight that has been acquired through several years of relevant industry experience, to propel our client’s business objectives.
- Adopt a culture of continuous learning to be on top of the latest changes and thereby chart a roadmap to success.
- To deliver high-quality professional regulatory services that fit your needs and deliver the results as per your expectations.
- To be your one-stop regulatory partner right from early development stage to successful launch and subsequent life cycle management.
Values
At Episteme, we strongly believe that our core values are crucial in determining our success and are our guiding force. We have incorporated the following values;
- Collaboration: Mutually beneficial long-term relationship with our client
- Integrity: Doing right always
- Reliability: Meeting commitment, taking ownership of work, and accountability for results
- Excellence in all our endeavors: Deliver the best outcome possible, with a strong focus on quality
Who we are
- We are pharma consultants with extensive, relevant, and current experience gained through decades of successful industry careers in major pharma companies.
- Our strength lies in a wide range of knowledge, experience, proven track record, and the capability to deliver an end-to-end strategy.
- Unparallel technical skill set required to navigate an ever-changing regulatory landscape.
- Experience and expertise for diverse and complex dosage forms such as liposomal injections, long-acting and depot injectables, pen and auto-injectors, peptides and other complex APIs, ophthalmic suspensions, nasal & inhalation products and Drug-Device combination products.
- Episteme can deliver quality with speed using our in-depth knowledge and unmatched scientific writing skills and pragmatic solutions.
- We bring differentiation with lateral thinking and focused approach thereby leveraging our client’s success.
Why do you need us?
Diverse Scope
Leveraging our deep understanding of the regulatory environment to support pharmaceutical companies in navigating critical areas like strategy, policy, regulatory intelligence, labeling and business continuity.
Challenges
The defined requirements are largely interpretive requiring an professional expert who can understand, correlate ambiguous requirements and to facilitate right decision.
Our Expertise
Our expertise enables to mitigate regulatory risk by developing compliant strategies.
We can provide efficient, seamless management of entire regulatory submission process and can cater to your unique requirement and promptly provide tailor made solutions for multifaceted challenges.
Partner of Choice
Team can add significant value to your business as a strategic partner offering comprehensive range of services.
We aspire to contribute to your success through our rich and diverse expertise.
Services
Regulatory strategy building
Strategy Significance
Episteme strongly believes that regulatory strategy is crucial and key right from product identification to securing a timely approval, launch, and product life cycle.
Proven expertise
Our consultants have a proven track record of getting approvals for several complex products and extensive knowledge and experience in defining sound and effective regulatory strategies.
Begin right
The strength of Episteme lies in its ability to understand requirements early in development and incorporate them in the early stages.
Understanding requirements
Leveraging our in-depth knowledge of regulatory agencies’ expectations, we excel at drafting Controlled Correspondences and meeting requests/packages for pre-IND, pre-ANDA/NDA meetings with USFDA, and scientific advice for EU and Canada.
Services
Dossier submission
Query response
Our expertise gained through years of experience helps clients to address regulatory deficiencies effectively. We support in drafting a comprehensive response ensuring all the concerns are addressed thoroughly and thereby getting faster product approval.
Capabilities
Comprehensive understanding and capabilities in preparing all modules and labeling. Fostering quality of submission through robust quality check process to ensure accuracy and completeness of every submitted dossier.
Services
Life cycle management
Change evaluation
Evaluating changes, deciding its reporting category, and guiding the cross-functional team on documents required.
Submission
Post-approval Supplement/variation preparation, review of documents, and submission of various supplements.
Responding to any queries promptly and completely to secure timely approval and ensure business continuity.
Expertise
Our team has vast experience in change management, right from evaluating correct reporting categories, and document requirements and thorough scientific writing skills.
Several 100’s of supplements have been successfully submitted; the reporting category has been granted and approved as per the defined timeline.
Services
Regulatory operations
eCTD publication and submission
Assemble publish and validate,
Compliance with electronic documentation requirements,
Ensuring that electronic production passes current technical validation criteria and troubleshooting validation errors.
Administrative Functions
Drug listing
Establishment registration
Labeler code/FEI
Facility Self-identification
GDUFA/PDUFA cover sheet
Contact Us
Location:
1103, Nilamber Triumph, Nilamber Circle, 30 mtr, Gotri - Vasna Rd, Vadodara, Gujarat 390021, India
Call:
+91 9773478695
Email:
contact@epistemepharma.com