Labela Regsources Private Limited

Commitment to excellence is a cornerstone of the Labela. Our commitment stretches beyond dossier preparation and innovative product portfolio. We drive our business consultancy on various aspects related to product selection, fixing the price, Appointing importer, information on rules and regulations, market conditions, competition, product viability. We also offer our best services and supports for your business expansion to the following countries.

Middle East African Countrie

• Vietnam
• Cambodia
• Mynamar
• Thailand
• Kenya
• Uganda
• Tanzania.
• CIS Countries
• Kyrgyzstan
• Uzbekistan
• Turkmenistan
• Georgia
• Tajikistan
• Belarus
• Kazakhstan
• Azerbaijan
• Ukraine
• Russia.

We undertake the full project i.e. after careful market survey we select products of priority for registration and also provide complete regulatory support till the registration stage.
Company registration

• In getting brand search and getting NOIP Acceptance from National Office of Intellectual Property
• Preparation of medical dossiers for registration of medical products
• Translation of medical dossiers into the local language before submission of documents to the
• Health Ministry for product registration
• Handling query if any on your behalf
• Execution of registration process until the procurement of registration certificates

Compilation of dossier as per latest country specific guidelines.
Dossier compilation as per :
Asean Common Technical Dossier (ACTD) Guidelines
South Africa (MCC-MRF-1) Guidelines
Brazil ANVISA Guidelines

Dossiers compilation for submissions in :

• Asia
• Africa
• Central America
• South America
• North America
• Dossier compilation in Common Technical Dossier (CTD) format for :
• Commonwealth of Independent States (CIS) Guidelines.
• South East / West Europe Guidelines.
• Drafts data for :
• BMR, MFR
• Process Validation,
• Analytical Validation,
• Stability Study reports,
• Dissolution profile,
• Certificate of analysis and related reports
• Reports on :
• Bioavailability / Bioequivalance Studies,
• Clinical Trials studies
• Justification for fixed dose combination
• Prepare Periodic Safety Update report (PSUR)
• Preclinical studies like Toxicity, Carcinogenicity, Teratology and Reproduction toxicity.
  

Prepare Summary of product (SPC), Pack Insert, Product Rationale :

• Expert Reports :
• Quality,
• Pre-clinical,
• Clinical
  

Overviews (Module 2) :

• Clinical
• Non-Clinical

We have excellent contacts all over the India and therefore we also provide liaison services for those who wish to search for suppliers of raw materials, products and processes, as well as for those who wish to expand their global presence in a very telling manner. Business consultancy is provided on various aspects related to imports, exports, regulations, market conditions, competition, product viability, etc.

We help overseas buyers for contract manufacture of various products on exclusive basis by using technical talent and expertise available with Indian manufacturers.

We are well equipped to meet all your other requirements like Drug Formulation & Bulk Drug API’s, Machinery, Chemicals, Instruments, Paramedical, Herbal Phytochemicals and Neutraceuticals, etc. from any part of India.

Liaison Service

• Liasoning work for international pharmaceutical companies in India to:
• Identify loan licence / third party manufacturers in India.
• Take care of local licencing formalities.
• Liaise with the Drug Controller General’s office for obtaining Marketing Authorization for new drugs.
• Organize clinical trials and BE studies on behalf of clients.
• Labela will take care on the supply side, see that products are supplied in time as per contract satisfying
• all conditions.

We can conduct several training programmes and interactive workshops on regulatory supports periodically. The nature and course content is tailored to suit specific managerial levels in the organization.

Labela also undertakes to develop and conduct courses with specific focus when specially requested by customers. These courses can be conducted at either Labela or at the customer's venue.

The Medical Writing services cater to the regulatory aspect by searching literature / Published studies / Journal Articles Or buying individual published articles from different sources.

• Service Provided
• Justification for fixed dose combination.
• Prepare Periodic Safety Update report (PSUR).
• Prepare Summary of product (SPC), Pack Insert, Product rationale.
• Expert Reports on - Quality, Pre-clinical, Clinical
• Overviews - Clinical / Non-Clinical (Module 2)
• Nonclinical Study Reports (Module 4)
• Clinical Study Reports (Module 5)

Reports prepared
More than 1000 reports are prepared overall for CIS Countries, Russia, Latin America, African countries, Middle East countries etc.

Analytical Solutions is a contract analytical laboratory that provides quality, timely and cost-efficient analytical services to the pharmaceutical.

Our Strengths :
Tie Up with well established FDA, NABL Certified approved lab to carry out analytical testing.

We add value by :
Helping our clients to conduct following analytical testing.
Product performance testing (including dissolution, release rate and content uniformity)
Release testing for Active Pharmaceutical Ingredients (APIs) and formulated drug products
Process Validation,
Analytical Validation,
Stability data studies,
Analytical Report,
Impurity profiles,
Related substances report
Dissolution profile
(All the data supported by necessary Chromatograms & Spectrums).

Reports prepared :
More than 100 reports are prepared overall for CIS Countries, Russia, Latin America, African countries, Middle East countries etc.

We also have active association with approved study centers with state of art facilities to perform BA/BE studies (single dose, multiple dose, 2-way, 3-way, replicate design & dose proportionality studies, immediate and modified release, various dosage forms of known molecules) as well as Phase I, II, & III clinical studies.

Bioequivalence studies is a science based regulatory affairs project which includes a combination of studies based on specialization. The main aim is to establish if rate and extent of absorption of the given sample of the drug is comparable with innovators formulation.

Our Strengths
Tie Up with well established study centers to carry out BA / BE / Clinical Studies.

We add value by
Helping clients carry out BA/BE studies in well established study centers, which are approved from local DCGI and international WHO, EU, US FDA, Geneva, TGA – Australia, Medsafe – New Zealand and Brazil – ANVISA.

BA/BE Studies Conducted
Conducted more than 200 Studies for Semi Regulated Market like CIS Countries, Russia, Latin America, African countries, Middle East countries etc.

Conducted over 5 studies for highly regulated market like Europe, TGA-Australia, South Africa, Brazil Anvisa.

Studies in which a drug is tested on animals and in other non-human test systems. Safety information from such studies are used to support an investigational new drug application. The main goals of pre-clinical studies (also named animal toxicology and nonclinical studies) are to determine a product's ultimate safety profile. For instance, drugs may undergo pharmacodynamics (PD), pharmacokinetics (PK), ADME, and toxicity testing through animal testing.

Our associate animal toxicological study centers are providing preclinical studies services to fulfill requirements of registration dossier.

Toxicity Studies :
Acute Toxicity
Subchronic Toxicity
Chronic Toxicity
Carcinogenicity
Mutagenicity
Reproduction / Teratology Studies etc.
Median lethal dose (LD 50)

Reports Prepared
More than 50 reports are prepared overall for CIS Countries, Russia, Latin America, African countries, Middle East countries etc.