Sopan is
founder of Universal Catalyst LLP. He has spent 18+ years in pharmaceutical
industry. He has expertise in areas that includes Quality Control, Analytical
Research and Development, Research and Development (R&D) support for
business acquisitions, brand acquisitions and Project Management for New
Product Launches for India and Emerging Markets.
While working as a technical expert on outsourcing and
in-licensing products, he has visited multiple CMO`s (Contract Manufacturing
Organizations), CRO`s (Contract Research Organizations), Third Party Testing
Laboratories and industry experts within and outside India.
The complex nature of the business and outsourcing related
multiple challenges in front of CMO`s, CRO`s and Third-party Testing
Laboratories are his area of expertise. Outsourcing industry needs support of
technical/non-technical expertise to resolve critical product development
issues, to resolve Analytical Method (development / validation / transfer)
related issues, to take care of ever changing regulatory requirements, support
for vendor audit, Support for regulatory audit etc. There is need to reduce the
product cycle time, to deliver the robust, quality product and attract the
partner companies or market leaders for sustainable partnerships.
It is his passion to face these challenges and assure win-win
solution to both the partners. With this zeal he has brought in new B2B
(Business to Business)platform which will support CMO`s, CRO`s and Third-party
testing laboratories to resolve complexity associated with outsourcing and
in-licensing business. This will result into building trust through quality
product development, attract new business opportunities and build sustainable
partnerships with envisioned companies.
Our Services
As the company name indicates, we catalyze your business
processes to increase the rate of success. We are in the business to boost your
business…!!
Backend Support
We have product support team composed of proficient scientists,
regulatory experts and experts in various fields, who work closely with
Contract Manufacturing and Contract Research Organizations to successfully
develop products from the early conception stage till product filing.
Dossier / Product Data Technical
Evaluation:
Our technical team evaluate product data / dossier (s) for
various markets for its correctness and completeness as per regulatory
requirements. We provide complete report on technical / non-technical gaps (If
any) in the dossier. We provide complete guidance/support to close on technical
/ non-technical gaps (If any) in the dossier to be filed. We support in
troubleshooting of all types of technical issues in product development and
also related to Analytical method development and validations.
Database:
Product technical/commercial evaluation process involves data
collection from in-house cross functional teams, compilation and to-and-fro
mails / telephonic discussions with partner to close on gaps as per target
market regulatory requirements. This will consume considerably high time which
further extends the product cycle time. Organizations can submit the product
data on our SSL certified secure database. This will allow partner companies to
find all required product details at one place. Product data can be
pre-evaluated by our technical teams against targeted market regulatory
requirements and CMO / CRO`s can publish final dossier for partner reviews.
Dossier will be provided to partner companies for review only after meeting
pre-set requirements by those companies.
Product Development:
Contract Manufacturers can take our support at right time like
early development stage/product ready to offer/ product under evaluation with
partner etc. to increase the rate of product acceptance by partner companies.
Every company target for first to launch (FTL) or to be within First Few To
Launch (FFTL) to market. Proactive approach by Contract Manufacturing
Organization and Contract Research Organization will always keep them ahead of
competitors.
Audit Support:
Our experts will support with pre-audit and provide complete
audit report for closure of gaps (If any) well before any major audit.
Companies / Laboratories can go through the detailed profiles of expert(s) /
consultant(s) and choose the specific subject expert.
Subject Experts:
We are publishing list of experts in various technical /
non-technical fields on our website. Companies/customers can go through the
detailed Expert profiles to understand the depth of subject experience. Experts
in the field of Pharmaceuticals / Nutraceuticals R&D, Analytical R&D,
Quality Compliance, Regulatory Affairs, Computer System Validations (CSV),
Manufacturing Facility Audit and Quality Audit etc. can be made available on
request. For fixing appointment, companies/customers can contact our Help Desk
through “Contact Us” OR “Ask Expert” available on individual expert page.
Help Desk:
Our Help Desk team will get back to you at the earliest possible
time for every request received from “Ask Expert” available on individual
product and expert page or “Contact Us” page.
Frontend
Support
Visibility (Product/Plant/Brand):
Visibility to right customer/partner is the key ingredient for
marketing success, it is very much important to save time and money. Product
data / dossier availability status shall reach to decision maker on a click.
Manufacturing facility (Capacity and Capability) related information to be
visible for all the decision makers. This shall support both the partners to
develop sustainable business relations. Based on business case of product for
targeted market, information about complete dossier availability and
manufacturing capacity (Scalability) it shall be well informed decision making
for partner companies.
Display of Product and Plant
Data:
Dossier / Product detailed data availability information will be
presented to partners / customers. Partners will be able to see the status of
the product and data availability on a click. Multiple products and complete
data availability status at one place. This will support fast decision-making
process to shortlist the contract manufacturer / Contract R&D for
particular product. On request by partners, we may provide complete dossier and
technical support for in-depth evaluation of the product.
Database:
www.ucatalyst.com website is a B2B (Business to Business)market
place for Pharmaceutical and Nutraceutical Products. CMO`s and CRO`s can
publish information about their manufacturing capacity and Research and
Development capacity. This data base is first of its kind and shall be very
supportive to Pharmaceutical and Nutraceutical company’s strategic planning.
Advertisement:
Advertisement to right decision makers will increase the
probability of increased order book. Companies can use this platform to reach out
to correct partners/customers. Advertising about technology updates, quality
updates and compliance initiatives, data integrity solution implementation,
updates in manufacturing capability/capacity, products/brands advertisement,
Analytical Laboratory upgrades, capability development into particular R&D
and analytical area etc. will result into increased order book. Right
advertisement can also be used for Brand building for products and
organizations.
Review comments and Rating:
Partner companies/customers will be able to provide review
comments on individual product. Also, we are providing facility to rate the
product on the scale of 1 to 5 star. Partner companies/customers can post the
product link to their Facebook, Twitter and LinkedIn account with one click.
Help Desk:
Companies/customers can take support from our Help Desk by
requesting information through “Ask Expert” available on individual product and
expert page. OR by requesting information through “Contact Us” page.
We are sure, we dont spam with bulk emails and your email address is safe and will not be shared with any third parties.