Services
The regulatory intelligence services provided by Oraculum solutions enable you to design a viable drug development, clinical, and commercialization strategy.
Regulatory Intelligence
Oraculum’s drug Regulatory intelligence (RI) team understands the importance of required Regulatory information, and how accurate should it be for a successful market-entry. Starting from addressing any focused Regulatory query,
overview of targeted country’s regulations or to assess the Regulatory needs prior to product registration,
Orculum tailors its RI solution for drug category to meet diverse needs of global pharmaceutical and biopharmaceutical companies.
Market Intelligence
Our market intelligence solutions empower businesses with in-depth insights required to analyze
market data and build new growth strategies.
Our expertise and experience enable us to offer tailored solutions that empower business leaders
to devise new strategies and position themselves for success. By providing timely, incisive insights
and market intelligence solutions, we help our clients meet their business goals and
objectives to gain a leading edge in the market.
Companies willing to register, market, import, or sell a medical device legally in India must follow
CDSCO requirements. In other cases, such as when a company does not have a local presence or
a registered office in India, an authorized agent acts as a liaison between the overseas manufacturer
and the government, handling registrations and post-market surveillance procedures.
A hired “Authorized Representative” will be accountable for the manufacturer’s business activities in
India, including all aspects of compliance with the regulatory authority’s Act. Only one India
“Authorized Agent” will be responsible for post-market surveillance and pre-certification for the entire country.
Oraculum will legally represent you in India without any financial conflicts of interest, such as product promotion, distribution, or sales.
Regulatory Intelligence
Oraculum’s drug Regulatory intelligence (RI) team understands the importance of required Regulatory information, and how accurate should it be for a successful market-entry. Starting from addressing any focused Regulatory query,
overview of targeted country’s regulations or to assess the Regulatory needs prior to product registration,
Orculum tailors its RI solution for drug category to meet diverse needs of global pharmaceutical and biopharmaceutical companies.
Market Intelligence
Our market intelligence solutions empower businesses with in-depth insights required to analyze
market data and build new growth strategies.
Our expertise and experience enable us to offer tailored solutions that empower business leaders
to devise new strategies and position themselves for success. By providing timely, incisive insights
and market intelligence solutions, we help our clients meet their business goals and
objectives to gain a leading edge in the market.
Companies willing to register, market, import, or sell a medical device legally in India must follow
CDSCO requirements. In other cases, such as when a company does not have a local presence or
a registered office in India, an authorized agent acts as a liaison between the overseas manufacturer
and the government, handling registrations and post-market surveillance procedures.
A hired “Authorized Representative” will be accountable for the manufacturer’s business activities in
India, including all aspects of compliance with the regulatory authority’s Act. Only one India
“Authorized Agent” will be responsible for post-market surveillance and pre-certification for the entire country.
Oraculum will legally represent you in India without any financial conflicts of interest, such as product promotion, distribution, or sales.
a) Clinical Evaluation Reports (CER)
b) Medical Sign Off
c) Labelling Service
d) End to end regulatory and registration support in global markets for Cosmetics, Food and dietary supplements
e) Regulatory Strategy
f) Staffing
